SWAN-GANZ BIPOLAR PACING CATHETER FOR FEMORAL INSERTION

Additional Manufacturer Narrative

AN ENGINEERING EVALUATION WAS INITIATED TO ASSESS FOR ANY MANUFACTURING-RELATED PROCESSES WHICH COULD BE CORRELATED TO THE COMPLAINT. BASED ON THE AVAILABLE INFORMATION, THERE IS NO EVIDENCE THAT SUPPORTS OR CONFIRMS THE FAILURE MODE IS ASSOCIATED TO A MANUFACTURING/DESIGN DEFECT. THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND THE PRODUCT PASSED WITHOUT NON-CONFORMANCES. AS PART OF THE MANUFACTURING PROCESS, A 100% OF THE UNITS GO THROUGH A BALLOON INFLATION INSPECTION.

Additional Manufacturer Narrative

A PRODUCT EVALUATION WAS COMPLETED ON THE RETURNED CATHETER. THE REPORTED EVENT OF "DID NOT INFLATE" WAS CONFIRMED. BALLOON DID NOT INFLATE DUE TO LEAKAGE FROM A TEAR CLOSE TO PROXIMAL WINDINGS. THE TEAR SIZE WAS APPROXIMATELY 0.5MM IN LENGTH. BALLOON LATEX WAS RELEASED FROM DISTAL WINDING TO CHECK BALLOON EDGES AT THE TEAR. THE EDGES OF TEAR DID NOT APPEAR MATCHING AT THE RUPTURE. NO OTHER VISIBLE DAMAGE OR ABNORMALITY WAS OBSERVED FROM CATHETER BODY AND WINDINGS. AN ENGINEERING EVALUATION WAS INITIATED TO ASSESS FOR ANY MANUFACTURING-RELATED PROCESSES WHICH COULD BE CORRELATED TO THE COMPLAINT. A SUPPLEMENTAL REPORT WILL BE FORTHCOMING WHEN THE INVESTIGATION IS COMPLETE. 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.

Description of Event or Problem

AS REPORTED, DURING BALLOON TEST BEFORE USE IN PATIENT, THE BALLOON OF A SWAN-GANZ PACING CATHETER DID NOT INFLATE. THERE WAS NO ALLEGATION OF PATIENT INJURY.