The FDA warned Insightra Medical last month about how it handles reporting and investigating failure complaints concerning its intra-aortic balloon catheters.
An FDA investigator inspected Insightra’s Irvine, Calif., facility in February and issued a Form 483 detailing the company’s failure to adequately establish procedures for receiving, reviewing, and evaluating complaints, according to a May 21 warning letter posted on the FDA’s website this week.
The failure included a review of 12 complaints, revealing that "4 were not adequately evaluated and investigated to determine the root cause of the device failure as exampled by complaint numbers."
Included in the reports was 1 claim in which, after a patient died, Insightra failed to obtain the IAB catheter device for evaluation after the failure.
"In instances when your distributor does not provide the information necessary to complete an investigation you should attempt to contact the end user (i.e. the complainant) directly; the end user contact information was included on complaint reports and there are no documented attempts to contact them directly," according to the letter.
Insightra’s medical device reporting procedures were also dinged by the federal watchdog, who stated Insightra had a "failure to adequately develop, maintain and implement written MDR procedures."
"The procedure does not establish internal systems that provide for timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements. The procedure does not establish internal systems that provide for timely transmission of complete medical device reports. The procedure does not describe how your firm will address documentation and record-keeping requirements," the letter details.
Insightra won FDA clearance for its Freedom Octomesh ventral hernia system late last month, saying the new device would be available later this year.
