SWAN-GANZ BIPOLAR PACING CATHETER FOR SVC INSERTION

Additional Manufacturer Narrative

THE DEVICE EVALUATION IS ANTICIPATED. HOWEVER, THE COMPLAINT CANNOT BE CONFIRMED WITHOUT THE COMPLETION OF A PRODUCT EVALUATION. 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.

Description of Event or Problem

AS REPORTED, DURING USE, A SWAN-GANZ PACING CATHETER STOPPED PACING. AFTER INSERTION AT THE CATHETER ROOM, IT WAS ABLE TO PACE WITHOUT PROBLEM FOR BACKUP PACING DURING TAVI OPERATION. AFTER THE OPERATION, THE PATIENT WAS MOVED TO THE ICU AND THEN THE CATHETER FAILED TO PACE. THE PATIENT WENT INTO CARDIAC ARREST TEMPORARILY, SO CHEST COMPRESSIONS WERE PERFORMED AND THE PATIENT'S CONDITION IMPROVED. THE CATHETER WAS REPLACED TO RESOLVE THE ISSUE. THE PATIENT'S OUTCOME IS UNDER ONGOING TREATMENT AND CURRENTLY RECOVERING.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WAS RECEIVED FROM CUSTOMER. AFTER THE PATIENT WAS MOVED TO THE ICU, THE PATIENT WENT INTO CARDIAC ARREST. THE PACING FAILURE WAS CONFIRMED AFTER THE CARDIAC ARREST. THIS PACING FAILURE OCCURRED WHEN THE DOCTOR LIGHTLY TOUCHED THE PACING CATHETER ON THE NECK. THE DOCTOR CHECKED THE THRESHOLD, BUT IT WAS FINE. IT WAS DIFFICULT TO CONSIDER THAT THERE WAS AN ABNORMALITY AT THE PLACEMENT POSITION OF THE CATHETER TIP. IT WAS SUSPECTED THAT THERE WAS A DISCONNECTION WITH THE CATHETER, BUT THE DETAILS WERE UNCLEAR. A LEADLESS PACEMAKER WAS PLACED ONCE THE PATIENT'S CONDITION IMPROVED. THE TEMPORARY PACING CATHETER WAS PLACED TO DEAL WITH ATRIOVENTRICULAR BLOCK AFTER THE OPERATION. THE PATIENT ORIGINALLY HAD A HISTORY OF ATRIOVENTRICULAR BLOCK, AND THE PATIENT WAS SCHEDULED TO HAVE A PACEMAKER PLACED. THE 6FR SHEATH INTRODUCER IN THE 8FR SHEATH INTRODUCER MANUFACTURED BY ARROW WAS USED AS SHEATH-IN-SHEATH. NO HOSPITALIZATION FOR TREATMENT NOR EXTENSION OF HOSPITALIZATION PERIOD WAS REQUIRED. THE PATIENT RECOVERED AND HAS BEEN DISCHARGED. A PRODUCT EVALUATION WAS COMPLETED ON THE RETURNED CATHETER. THE REPORTED EVENT 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 MIN. WITHOUT LEAKAGE. PRODUCT EVALUATION CONFIRMED THAT NO DEFECT WAS FOUND; THEREFORE, A PRODUCT NON-CONFORMANCE OR DEVICE FAILURE COULD NOT BE CONFIRMED FOR "PACING DIFFICULTY" MALFUNCTION CODE. THE LOT NUMBER WAS NOT PROVIDED THUS A DEVICE HISTORY RECORD WAS NOT REVIEWED. AS PART OF THE MANUFACTURING PROCESS, 100% OF THE UNITS GO THROUGH AN ELECTRICAL INSPECTION PROCESS. THE INSTRUCTIONS FOR USE (IFU) PROVIDES THE FOLLOWING WARNINGS AND PRECAUTIONS: THIS CATHETER REQUIRES SPECIAL TECHNIQUES FOR INSERTION AND REMOVAL. ELECTRODE DISLODGEMENT MAY RESULT FROM PULLING THE CATHETER OUT THROUGH THE PERCUTANEOUS SHEATH. AVOID FORCEFUL WIPING OR STRETCHING OF THE CATHETER DURING TESTING AND CLEANING AS NOT TO BREAK THE ELECTRODE WIRE CIRCUITRY. 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.