TARGET XL 360 SOFT 20MM X 50CM

Additional Manufacturer Narrative

DUE TO THE AUTOMATED MANUFACTURING EXECUTION SYSTEM (MES) SYSTEM THERE ARE CONTROLS IN THE MANUFACTURING PROCESS TO ENSURE THE PRODUCT MET SPECIFICATIONS UPON RELEASE. DURING VISUAL INSPECTION THE SUBJECT MAIN COIL WAS RETURNED OUTSIDE OF THE INTRODUCER SHEATH. THE SUBJECT MAIN COIL WAS STRETCHED AND TANGLED. A SECTION OF THE MAIN COIL WAS BROKEN/FRACTURED. THE SUBJECT COIL DELIVERY WIRE WAS KINKED/BENT. THE PROXIMAL CONTACT WAS NOTED TO BE INTACT. THE FUNCTIONAL INSPECTION WAS NOT PERFORMED. THE REPORTED EVENT IS COVERED IN THE DEVICE DIRECTION FOR USE (DFU). AS WELL, THE RISK OF THE REPORTED EVENT IS DOCUMENTED IN THE RISK DOCUMENTATION AND THERE ARE CURRENT CONTROLS TO MITIGATE THE RISK OF THE AS REPORTED EVENT. THE REPORTED "MAIN COIL FAILED/UNABLE TO DETACH" IT COULD NOT BE REPLICATED DURING DEVICE ANALYSIS HOWEVER, THE ANALYSIS RESULTS ARE CONSISTENT WITH THE REPORTED EVENT. THE DEVICE FAILED TO MEET SPECIFICATIONS WHEN RECEIVED FOR COMPLAINT INVESTIGATION BASED ON THE ANALYZED ANOMALIES NOTED TO THE DEVICE. IT WAS REPORTED THAT DURING THE PROCEDURE, WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY THE SUBJECT COIL, IT COULD NOT BE DETACHED SO THEY WITHDRAW THE COIL. ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER INDICATED THAT THE DEVICE WAS PREPARED FOR USE AS PER THE DFU. PROXIMAL END OF THE DELIVERY WIRE WAS NOT WIPED WITH ALCOHOL PRIOR TO INSERTING INTO THE POWER SUPPLY. THERE WAS NO DAMAGE NOTED TO THE PACKAGING PRIOR TO OPENING THE PACKAGING. THE DEVICE WAS CONFIRMED TO BE IN GOOD CONDITION DURING PREPARATION/ PRIOR TO USE ON THE PATIENT. CONTINUOUS FLUSH WAS SET UP AND MAINTAINED THROUGHOUT THE CLINICAL PROCEDURE. THE DEVICE WAS RETURNED FOR ANALYSIS. THE SUBJECT MAIN COIL WAS FOUND TO BE EXTREMELY STRETCHED AND TANGLED. A SECTION OF THE SUBJECT MAIN COIL WAS BROKEN AND FRACTURED, WITH THE SUTURE ALSO DAMAGED. ADDITIONALLY, THE SUBJECT COIL DELIVERY WIRE WAS OBSERVED TO BE KINKED. PROXIMAL END OF THE SUBJECT COIL DELIVERY WIRE WAS NOT WIPED WITH ALCOHOL PRIOR TO INSERTING INTO THE POWER SUPPLY IT IS PROBABLY CAUSE THE REPORTED DEFECT THEREFORE AN ASSIGNABLE CAUSE OF ¿USE ERROR' WILL BE ASSIGNED TO AS REPORTED "MAIN COIL FAILED/UNABLE TO DETACH" AS ISSUE INVESTIGATION CONFIRMS THAT THERE WAS AN ACT OR OMISSION OF AN ACT THAT RESULTED IN A DIFFERENT MEDICAL PRODUCT RESPONSE THAN INTENDED BY THE MANUFACTURER AND/OR EXPECTED BY THE USER. A DEVIATION FROM THE SUPPLIED DFU THAT RESULTED IN A DIFFERENT MEDICAL PRODUCT RESPONSE THAN INTENDED BY THE MANUFACTURER OR EXPECTED BY THE USER. BASED ON THE ALL-AVAILABLE INFORMATION AND ANALYSIS OF THE DEVICE IT IS PROBABLE THAT THE SUBJECT COIL PULLED AGAINST RESISTANCE OR IT MAY HAVE OCCURRED DURING THE PACKAGING OF THE DEVICE FOR RETURN WHICH MAY CAUSE ANALYZED CODES THEREFORE AN ASSIGNABLE CAUSE OF 'HANDLING DAMAGE' WILL BE ASSIGNED TO THE AS ANALYZED 'MAIN COIL BROKEN/FRACTURED DURING USE, MAIN COIL STRETCHED, MAIN COIL TANGLED, MAIN COIL SUTURE DAMAGE, COIL DELIVERY WIRE KINKED/BENT' SINCE THIS ISSUE IS MOST LIKELY DUE TO HANDLING OF THE PRODUCT OR PORTION OF THE PRODUCT DURING THE CLINICAL PROCEDURE, UPON REMOVAL OF THE PRODUCT FROM THE PACKAGING, OR PREPARATION OF THE PRODUCT PRIOR TO USE.

Description of Event or Problem

IT WAS REPORTED THAT THE SUBJECT MAIN COIL FAILED TO DETACH. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT. THE SUBJECT DEVICE WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT THE SUBJECT MAIN COIL WAS BROKEN/FRACTURED DURING USE. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.