The FDA has warned Spectranetics, a manufacturer of laser sheaths, for issues with its device risk assessments following patient deaths.
Deaths were reported with the GlideLight Laser Sheath/SLS devices beginning in 2014, and the warning letter suggests a higher severity rating in the risk analysis would have been appropriate in light of the deaths and “multiple complaints.” The severity rating will be assessed during the next inspection “since risk should be continually reviewed as additional postmarket data becomes available, per your procedures,” says the May 23 warning letter.
Spectranetics has multiple risk analysis documents that it can reference to determine risk ratings, but it lacks a set methodology to ensure uniform probabilities are assigned to each risk across the different documents, the letter adds.
Inadequate Process Validation
Validation issues also drew the FDA’s attention during the inspection period from Nov. 30, 2015, to Jan. 21, 2016. The company had not validated a process used to manufacture part of the outer jackets subassembly of certain devices.
The company’s laser systems include a Class IV laser, and the outer jackets contain the laser. “Complaints have been reported for failures such as cracks, splits, damage to the outer jacket and/or sparks and visible laser light through the outer jacket,” the letter says.
Spectranetics’ process validation for a process related to the Class III GlideLight and SLS Laser Sheath finished devices was also deemed inadequate because it lacked a component of the company’s test protocol requirements.
During the inspection, the FDA found that Spectranetics made changes after an initial protocol was approved. The letter notes that acceptance criteria should be clearly defined before any validation, and any deviations should be evaluated, with justifications of why they may be acceptable. Evaluation of the process and related deviations may require revalidation, the agency says.
The company made another change between the protocol being written and performed, but the investigator did not find an assessment of how the change might affect the finished product. Due to the procedural deficiencies, “several CAPA records are deficient,” the letter says.
Another citation noted that Spectranetics identified multiple nonconformances, with common cause statements suggesting a potential cause from a certain process. However, the firm did not analyze the common process to identify and prevent further nonconformances.
In addition to being a medical device, Spectranetics’ surgical laser systems are “electronic products” and must comply with certain regulations for Electronic Product Radiation Control. However, the company has not submitted Accidental Radiation Occurrence reports for some complaints where the outer jacket of the fiber catheter sheath was damaged, leading to “visible light, sparks and minor burns.” The FDA investigator found complaint records that should have been reported as AROs, according to the letter.
The company told IDDM it plans to respond to the FDA , and it believes that its response will involve updates in processes and documentation but won’t have a material impact on its business. Spectranetics stresses that the warning letter does not require the withdrawal of any product from the marketplace.
“We have already addressed several of the issues brought up in the Form 483’s, which were disclosed in our most recent Form 10-K. As a medical device manufacturer we have to report incidents where deaths occur when our devices are used, regardless of the cause of death,” Spectranetics told IDDM.
Read the warning letter here: www.fdanews.com/06-07-16-Spectranetics.pdf. — April Hollis