FDA Notes MDR Issues in Form 483 to Avinger

Avinger has received a Form 483 for failing to submit a medical device report (MDR) to the FDA after receiving information suggesting one of its devices may have led to patient injury. During a Jan. 25 to Feb. 2 inspection of Avinger’s Redwood City, Calif., facility, the FDA’s San Francisco District Office noted a Nov. 17, 2009, complaint that “the device [Wildcat Guidewire Support Catheter W400] was tracking intraluminally at the time of perforation.” Avinger did not submit an MDR to the FDA within 30 days of receiving this report, the form says. Avinger’s Wildcat device is a “multifunctional tool to aid proper guidewire positioning,” according to the company.
The GMP Letter