VOLUMEVIEW FEMORAL CATHETER KIT

Additional Manufacturer Narrative

THE MANUFACTURING RECORDS WERE REVIEWED AND THERE IS NO INDICATION OF A RELATED NONCONFORMANCE. ALL PROCESS PARAMETERS WERE MET AND INSPECTIONS PASSED SUCCESSFULLY. BASED ON FURTHER ENGINEERING EVALUATION, AS PART OF THE MANUFACTURING PROCESS THE GUIDEWIRE INSPECTION IS PERFORMED. ADDITIONALLY, A VISUAL AND DIMENSIONAL INSPECTION PROCESS IS PERFORMED TO THE THE PURCHASED DILATORS AS PART OF THE INCOMING INSERTION PROCESS. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS ON A MONTHLY BASIS, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS MONTHLY REVIEW.

Description of Event or Problem

AS REPORTED, DURING INSERTION OF THE FEMORAL ARTERY CATHETER OF THIS VOLUME VIEW SET (MEDWATCH 32833), USER FELT RESISTANCE WHEN INTRODUCING THE GUIDEWIRE. IT WAS REMOVED WITHOUT PROBLEMS AND A NEW GUIDEWIRE FROM A NEW VOLUME VIEW KIT (MEDWATCH 32834) WAS TRIED TO BE INSERTED IN THE FEMORAL ARTERY IN THE OTHER LEG. HOWEVER, RESISTANCE WAS FELT AGAIN, AND THIS SECOND GUIDEWIRE GOT STUCK. VASCULAR SURGEON WAS CALLED TO REMOVE THE DEVICE BY A PERCUTANEOUS INTERVENTION. UPON REMOVAL, THE GUIDEWIRE WAS FOUND FRAYED. PATIENT DIED SOME DAYS AFTER FOR UNKNOWN AND UNRELATED CAUSE TO THIS EVENT. THE DEVICES WERE AVAILABLE FOR EVALUATION. AS A SUMMARY TWO MEDWATCH REPORTS WILL BE SUBMITTED, ONE FOR EACH DEVICE (32833 AND 32834).

Additional Manufacturer Narrative

NO PRODUCT WAS RETURNED FOR EVALUATION; IT WAS DISCARDED AT THE HOSPITAL. WITHOUT THE RETURN OF THE PRODUCT, IT IS NOT POSSIBLE TO DETERMINE IF DAMAGES OR DEFECTS EXISTED ON THE PRODUCT, NOR COULD A ROOT CAUSE OR POTENTIAL CONTRIBUTING FACTORS BE IDENTIFIED.