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Patient 1
ONE D97130F5 WITH MONOJECT LIMITED VOLUME SYRINGE AND NON-EDWARDS CONTAMINATION SHIELD WERE RETURNED FOR EXAMINATION. THE REPORTED EVENT OF PACING ISSUE WAS CONFIRMED. THE PROXIMAL ELECTRODE CIRCUIT WAS FOUND TO BE OPEN. A CUT DOWN ON THE CATHETER BODY FOUND THE PROXIMAL LEAD WIRE WAS BROKEN APPROXIMATELY 1.8CM PROXIMAL OF THE DISTAL TIP. INSULATION WAS NOT PRESENT ON THE LEAD WIRE AT THE LOCATION OF DAMAGE. THE DISTAL ELECTRODE CIRCUIT WAS FOUND TO BE CONTINUOUS. THE BALLOON INFLATED CLEAR AND CONCENTRIC AND REMAINED INFLATED FOR 5 MINUTES WITHOUT LEAKAGE. NO VISIBLE ABNORMALITY WAS OBSERVED FROM THE CATHETER BODY. A REVIEW OF THE MANUFACTURING RECORDS INDICATED THAT THE PRODUCT MET SPECIFICATIONS UPON RELEASE. AN ENGINEERING EVALUATION HAS BEEN INITIATED TO ASSESS FOR ANY MANUFACTURING-RELATED PROCESSES WHICH COULD BE CORRELATED TO THE COMPLAINT. SWAN-GANZ PACING THERMODILUTION (TD) CATHETERS SERVE AS DIAGNOSTIC AND THERAPEUTIC TOOLS IN THE MANAGEMENT OF CRITICALLY ILL PATIENTS. THERE ARE MULTIPLE FAILURE MODES THAT MAY REQUIRE THE EXCHANGE OF A PACING CATHETER. SINCE PROPER FUNCTIONING OF THE PACING CATHETER DEPENDS ON THE ELECTRICAL CONTINUITY OF ITS ELECTRODES AND INTERNAL WIRES, CARE SHOULD BE EXERCISED WHEN HANDLING THE CATHETER. STRETCHING, KINKING, OR FORCEFUL WIPING OF THE CATHETER MAY RESULT IN DAMAGE. AFTER STABLE PACING HAS BEEN CONFIRMED, THE PROXIMAL END OF THE CATHETER SHOULD BE SECURED TO THE INSERTION SITE TO PREVENT UNDUE MOVEMENT THAT COULD RESULT IN TIP DISLODGMENT AND LOSS OF CAPTURE, OR CATHETER MIGRATION. CARE SHOULD BE TAKEN NOT TO KINK THE CATHETER BODY WHEN SECURING IT. IN THIS COMPLAINT, IT COULD NOT BE DETERMINED IF PROCEDURAL FACTORS OR DEVICE HANDLING MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. 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. UDI # (B)(4).