It was reported through the pmcf (post-market clinical follow-up) report, that the abbott otw mini trek ii coronary dilatation catheters (cdcs) that were used may be related to vessel dissection, arrhythmias including ventricular fibrillation, perforation, myocardial infarction.The report also found performance issues with the otw mini trek ii cdcs such as issues with delivery, inflation, deflation, and withdrawal.
|
Date of event ¿ estimated.The unique device identifier (udi) is unknown because the part number and lot number were not provided.The devices were not returned for evaluation.A review of the lot history records could not be conducted because the part and lot numbers were not provided.The investigation determined a conclusive cause for the reported difficulties cannot be determined.There is no indication of a product quality issue with respect to manufacture, design, or labeling.The additional patient effects listed in the report are captured under a separate medwatch report.
|