The FDA slapped a warning letter on a California manufacturer of balloon catheters and inguinal hernia implants for not adequately evaluating complaints.
During a Feb. 19 to 24 inspection of the Insightra Medical’s Irvine, Calif., facility, investigators determined that four of 12 complaints were not adequately investigated to determine the cause of device failure. In one case, involving a patient’s death, the firm had very limited information on the patient and event, the May 21 letter says. The company conducted an investigation with the device distributor, but the catheter involved in the death was not made available and no further conclusions could be made.
In instances where a distributor doesn’t provide information necessary for an investigation, the manufacturer should contact the end user directly, the FDA says. While the user contact information was included in the complaint report, there were no documented attempts to contact the user, the agency adds.
When a device is not returned, companies should test reserve samples or devices manufactured around the same time, review device history records, and analyze any service records or CAPA or nonconforming data related to the device, the FDA says.