TARGET 360 ULTRA 4MM X 15CM

Description of Event or Problem

THE SUBJECT COIL WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT THE SUBJECT MAIN COIL WAS BROKEN/FRACTURED DURING USE. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT REPORTED AS A RESULT OF THIS EVENT.

Additional Manufacturer Narrative

DUE TO THE AUTOMATED MANUFACTURING EXECUTION SYSTEM (MES) THERE ARE CONTROLS IN THE MANUFACTURING PROCESS TO ENSURE THE PRODUCT MET SPECIFICATIONS UPON RELEASE. DURING VISUAL/MICROSCOPIC INSPECTION, THE MAIN COIL WAS SEEN TO BE BROKEN/FRACTURED UPON RETURN. THE MAIN COIL WAS STRETCHED AND TANGLED. THE DETACHMENT ZONE WAS INTACT. THE COIL DELIVERY WIRE WAS KINKED/BENT. THE PROXIMAL CONTACT WAS NOTED TO BE INTACT. FUNCTIONAL INSPECTION WAS NOT APPLICABLE AS DEFECT WAS CONFIRMED DURING VISUAL INSPECTION. THE REPORTED ¿MAIN COIL STRETCHED¿ WAS CONFIRMED DURING ANALYSIS. THE DEVICE FAILED TO MEET SPECIFICATIONS WHEN RECEIVED FOR COMPLAINT INVESTIGATION BASED ON THE ANALYZED ANOMALIES NOTED TO THE DEVICE. THE REPORTED EVENT IS COVERED IN THE DEVICE DIRECTIONS 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. IT WAS REPORTED THAT DURING THE PROCEDURE, PHYSICIAN EXPERIENCE SUBJECT COIL STRETCHED INSIDE THE MICROCATHETER WHILE DEPLOYMENT. ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER INDICATED THAT THE DEVICE WAS PREPARED FOR USE AS PER THE DFU. 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. PATIENT'S ANATOMY MODERATELY TORTUOUS. THE DEVICE WAS RETURNED FOR ANALYSIS. THE MAIN COIL WAS FOUND TO BE EXTREMELY STRETCHED AND TANGLED. THE DETACHMENT ZONE OF MAIN COIL WAS INTACT BUT SECTION OF IT BROKEN AND FRACTURED, WITH THE SUTURE ALSO DAMAGED. ADDITIONALLY, THE COIL DELIVERY WIRE WAS OBSERVED TO BE KINKED. REPORTED DEFECTS CONFIRMED DURING ANALYSIS. THERE IS NO DEFINITIVE EVIDENCE TO SUPPORT THE REPORTED EVENT BUT IT PROBABLE THAT IT MAY OCCURRED DUE TO SOME HUMAN ANATOMICAL FACTORS SUCH AS MODERATELY TORTUOUS OR PROCEDURAL FACTORS THEREFORE AN ASSIGNABLE CAUSE OF 'PROCEDURAL FACTORS' WILL BE ASSIGNED TO AS REPORTED AND AS ANALYZED "MAIN COIL STRETCHED " AS THIS COMPLAINT APPEARS TO BE ASSOCIATED WITH A PRODUCT THAT MET STRYKER DESIGN AND MANUFACTURING SPECIFICATIONS AND WAS USED IN ACCORDANCE WITH THE DFU, BUT PERFORMANCE WAS LIMITED DUE TO PROCEDURAL FACTORS DURING USE. 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 DEFECT THEREFORE AN ASSIGNABLE CAUSE OF 'HANDLING DAMAGE' WILL BE ASSIGNED TO THE AS ANALYZED MAIN COIL BROKEN/FRACTURED DURING USE, MAIN COIL TANGLED, SUTURE DAMAGED, 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.