SWAN-GANZ BIPOLAR PACING CATHETER FOR FEMORAL INSERTION

Additional Manufacturer Narrative

ONE BIPOLAR PACING CATHETER WITH ATTACHED MONOJECT LIMITED VOLUME SYRINGE WAS RETURNED FOR PRODUCT EVALUATION. THE CUSTOMER REPORT OF PACING ISSUE WAS UNABLE TO BE CONFIRMED. NO VISIBLE DAMAGE OR ABNORMALITY WAS OBSERVED FROM CATHETER BODY, BALLOON OR WINDINGS. CONTINUITY TESTING WAS PERFORMED ON THE DISTAL AND PROXIMAL CIRCUITS AND THERE WERE NO OPEN, INTERMITTENT, OR SHORT CONDITIONS OBSERVED. THE BALLOON INFLATED CLEAR AND CONCENTRIC WITH 1.3 CC AIR AND THE BALLOON REMAINED INFLATED FOR 5 MINUTES WITHOUT LEAKAGE. THE DEVICE HISTORY RECORD REVIEW WAS NOT COMPLETED AS THE LOT NUMBER WAS NOT PROVIDED. AN ENGINEERING EVALUATION WAS INITIATED TO ASSESS FOR ANY MANUFACTURING-RELATED PROCESSES WHICH COULD BE CORRELATED TO THE COMPLAINT. SINCE THE UNIT WAS RETURNED FOR EVALUATION, AND NO DEFECT WAS FOUND THERE IS NO EVIDENCE THAT SUPPORTS OR CONFIRMS THE FAILURE MODE IS ASSOCIATED TO A MANUFACTURING OR DESIGN DEFECT. AS PART OF THE MANUFACTURING PROCESS 100% OF THE UNITS GO THROUGH AN ELECTRICAL INSPECTION PROCESS. THE INSTRUCTIONS FO RUSE ALSO CONTAINS INSTRUCTIONS TO HANDLE THE CATHETER WITH CAUTION FOR PROPER FUNCTIONING OF THE PACING CATHETER.

Description of Event or Problem

IT WAS REPORTED THAT DURING USE OF THE SWAN-GANZ PACING CATHETER IT DID NOT SENSE. THE BRAND/SIZE OF THE INTRODUCER USED IS UNKNOWN. THERE WAS NO ALLEGATION OF PATIENT INJURY.

Additional Manufacturer Narrative

THE DEVICE EVALUATION IS ANTICIPATED. A SUPPLEMENTAL REPORT WILL BE FORTHCOMING WHEN THE INVESTIGATION IS COMPLETED. 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 A PART OF THE MONTHLY REVIEW.