NA

Description of Event or Problem

IT WAS REPORTED THE CATHETER CURVE WON'T STRAIGHTEN - CAN'T ADVANCE THROUGH SHEATH. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

Additional Manufacturer Narrative

THE DEVICE WAS RETURNED TO STRYKER SUSTAINABILITY SOLUTIONS FOR EVALUATION. UPON VISUAL INSPECTION OF THE RECEIVED COMPLAINT DEVICE, DAMAGE TO THE CATHETER DISTAL TIP WAS OBSERVED. INSPECTION OF THE DISTAL TIP REVEALED TWO BENDS LOCATED APPROXIMATELY AT 4 CM AND 10 CM FROM THE DISTAL TIP. NO FURTHER RELEVANT VISIBLE DAMAGE WAS OBSERVED. THE LOCATION OF THE SHAFT DEFORMATIONS (KINK/BEND) WERE IDENTIFIED USING A CALIBRATED STEEL RULER. THE DEVICE WAS EVALUATED AND THE CATHETER DID NOT FORM A CURVE CONSISTENT WITH THE SPECIFICATION. ADDITIONALLY, DURING INSPECTION OF THE CURVE, IT WAS OBSERVED THAT THE DISTAL DEFORMATIONS LIKELY CONTRIBUTED TO THE DISTORTION OF THE CURVE, AS THE LOCATIONS OF THE KINK/BEND COINCIDED WITH THE AREAS WHERE THE CURVE DISTORTION FORMED DURING DEFLECTION. THE INSPECTION RESULTS DETERMINED THAT THE COMPLAINT IS CONFIRMED FOR THE REPORTED FAILURE MODE. A REVIEW OF THE DHR SUPPORTS THAT THE DEVICE MET ALL INSPECTION AND TEST CRITERIA PRIOR TO RELEASE FROM STRYKER. THEREFORE, THE LIKELY ROOT CAUSE IS A CURVE FAILURE AS A RESULT OF MISHANDLING SUBSEQUENT TO DISTRIBUTION, INCLUDING SHIPPING AND STORAGE CONDITIONS OR IMPROPER MANIPULATION OF THE DEVICE. THE INSTRUCTIONS FOR USE (IFU) STATE: ¿ DO NOT ATTEMPT TO USE THE REPROCESSED EP CATHETER PRIOR TO COMPLETELY READING AND UNDERSTANDING THE DIRECTIONS FOR USE. ¿ DO NOT ALTER THIS DEVICE. ¿ INSPECT THE PACKAGING AND CATHETER FOR DAMAGE OR DEFECTS PRIOR TO USE. ¿ AVOID EXCESSIVE TORQUE, STRETCHING, KINKING AND/OR BENDING OF CATHETER, AS THIS MAY INTERFERE WITH DISTAL TIP SHAPING OR CAUSE DAMAGE TO INTERNAL ELECTRODE WIRES. ¿ AVOID MANUAL PRE-BENDING OF DISTAL CURVE, AS THIS MAY DAMAGE STEERING MECHANISM OF STEERABLE CATHETERS. HANDLE CATHETER WITH CARE TO AVOID IMPROPER ELECTRICAL FUNCTIONING. ¿ AVOID EXCESSIVE CONTACT OF HANDPIECE WITH FLUIDS, AS THIS COULD ADVERSELY AFFECT THE ELECTRICAL PERFORMANCE OF THE CATHETER. THE REPORTED EVENT WILL CONTINUE TO BE MONITORED THROUGH POST-MARKET SURVEILLANCE.