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Additional Manufacturer Narrative

THE DEVICE WAS RETURNED TO STRYKER SUSTAINABILITY SOLUTIONS FOR EVALUATION. UPON INSPECTION OF THE RECEIVED COMPLAINT DEVICE, A BEND WAS IDENTIFIED 8 CM FROM THE DISTAL TIP; WHICH IS DISTAL TO THE TRANSITION POINT. THE HANDLE, STEERING KNOB, AND CONNECTOR PINS APPEAR TO BE INTACT. THE DEVICE WAS EVALUATED. THE DEVICE DID NOT MEET THE CURVE OR PLANARITY SPECIFICATION. A REVIEW OF THE DHR SUPPORTS THAT THE DEVICE MET ALL INSPECTION AND TEST CRITERIA PRIOR TO RELEASE FROM STRYKER. THE REPORTED EVENT COULD BE ATTRIBUTED TO A BEND DISTAL TO THE TRANSITION POINT AS A RESULT OF MISHANDLING SUBSEQUENT TO DISTRIBUTION, INCLUDING SHIPPING/STORAGE CONDITIONS OR IMPROPER MANIPULATION OF THE CATHETER. THE INSTRUCTIONS FOR USE (IFU) STATE: INSPECT THE CATHETER FOR OVERALL CONDITION AND PHYSICAL INTEGRITY. DO NOT USE THE CATHETER IF ELECTRODES APPEAR LOOSE OR IF ANY DAMAGE IS NOTED. IF SUCH PROBLEMS EXIST, RETURN THE CATHETER AND PACKAGING TO STRYKER SUSTAINABILITY SOLUTIONS. CONNECT THE CATHETER TO THE CORRESPONDING CABLE CONNECTOR. CONNECT THE CABLE TO THE CORRECT ELECTRONIC EQUIPMENT FOR RECORDING AND/OR SENSING. OBSERVE POLARITY OF PROXIMALLY LOCATED CONNECTOR PINS OF THE INTERFACE CABLE WHEN CONNECTING TO THE ELECTRONIC EQUIPMENT. ISOLATE ANY UNUSED CONNECTOR PINS TO REDUCE DEVELOPMENT OF ACCIDENTAL CURRENT PATHWAYS TO THE HEART. FOLLOW A SUITABLE ELECTROPHYSIOLOGY STUDY PROTOCOL. DO NOT AUTOCLAVE CATHETER. DO NOT USE FOR ELECTRICAL ABLATION. AVOID EXCESSIVE CONTACT OF HANDPIECE WITH FLUIDS, AS THIS COULD ADVERSELY AFFECT THE ELECTRICAL PERFORMANCE OF THE CATHETER. DIAGNOSTIC EP CATHETERS ARE NOT RECOMMENDED FOR LONG TERM PACING. THE REPORTED EVENT WILL CONTINUE TO BE MONITORED THROUGH POST-MARKET SURVEILLANCE.

Description of Event or Problem

IT WAS REPORTED THE PRODUCT WAS BENT AND UNABLE TO HOLD SHAPE. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION. NO INFORMATION WAS PROVIDED REGARDING PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.