BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH HYD

    MDR report key: 1172754 · Received September 22, 2008

    Report

    Report Number
    2024168-2008-00832
    Event Type
    Malfunction
    Date Received
    September 22, 2008
    Date of Event
    August 21, 2008
    Report Date
    August 21, 2008
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    DQX
    PMA / PMN Number
    K013833
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: QUALITY ENGINEERING WAS UNABLE TO DETERMINE A ROOT CAUSE FOR THE GUIDE WIRE SEPARATION. EVALUATION SUMMARY: QUALITY ASSURANCE ANALYSIS REVEALED THAT THE GUIDE WIRE WAS RETURNED WITH BLOOD AND CONTRAST VISIBLE ON THE CORE AND COILS. THE CORE WAS SEPARATED AT THE PROXIMAL END OF THE HYPOTUBE. THE FRACTURE FACES WERE OVALED AS IF KINKED PRIOR TO SEPARATION. THERE WAS A KINK IN THE SHAPING RIBBON 4.5 MM PROXIMAL TO THE TIPBALL. THERE WERE OFFSET INTERMEDIATE COILS PROXIMAL TO THE CENTER SOLDER FOR A LENGTH OF 1.6 CM. THERE WAS NO OTHER DAMAGE NOTED TO THE GUIDE WIRE. THE GUIDE WIRE WAS SENT TO THE SCANNING ELECTRON MICROSCOPY (SEM) LAB FOR FURTHER ANALYSIS. PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFORMATION AND THE ANALYSIS OF THE RETURNED BMW GUIDE WIRE. IT WAS REPORTED THAT THE GUIDE WIRE WAS FOUND BENT AT THE AREA ALMOST 40 MM FROM THE TIP WHEN UNPACKING. ANALYSIS FOUND A KINK IN THE SHAPING RIBBON 4.5 MM PROXIMAL TO THE TIPBALL AND FOUND OFFSET INTERMEDIATE COILS PROXIMAL TO THE CENTER SOLDER FOR A LENGTH OF 1.6 CM. THE ANALYSIS OF THE RETURNED DEVICE DID NOT IDENTIFY THE SOURCE OF THE DAMAGE, BUT THE GUIDE WIRE TIP IS VERY FRAGILE AND CAN EASILY BE DAMAGED. THIS CAN HAPPEN IN MANUFACTURING, DURING TRANSPORTATION, IN REMOVAL FROM THE PACKAGING OF IN PREPARATION FOR USE. IN AN ATTEMPT TO ELIMINATE THE OCCURRENCES RELATED TO MANUFACTURING, INPROCESS CONTROLS ARE USED TO HELP ASSURE THAT THIS WAS NOT A MANUFACTURING ISSUE. WITH THE AVAILABLE INFORMATION, THE EXACT ROOT CAUSE IN THIS INSTANCE COULD NOT BE DETERMINED. ANALYSIS ALSO FOUND THE CORE SEPARATED AT THE PROXIMAL END OF THE HYPOTUBE. THE FRACTURE FACE WERE OVALED AS IF KINKED PRIOR TO SEPARATION. SEM ANALYSIS OF THE GUIDE WIRE CORE SHOWS THAT THE FAILURE COULD BE ATTRIBUTED TO A DUCTILE OVERLOAD A BEND, WHICH IS SUPPORTED BY THE OVALED FRACTURED FACES. THE GUIDE WIRE WAS THEREFORE SUBJECTED TO FORCES THAT EXCEEDED THE STRENGTH OF THE DEVICE. THE INCIDENT INFORMATION DID NOT DESCRIBE HOW THE WIRE MAY HAVE BEEN BENT. GUIDE WIRES ARE FRAGILE AND IT IS POSSIBLE THAT DURING REMOVAL OF THE GUIDE WIRE FROM THE DISPENSER HOOP, PREPARATION OF THE GUIDE WIRE FOR USE, HANDLING OR PACKING THE GUIDE WIRE FOR RETURN BACK TO ABBOTT FOR ANALYSIS, THAT A BEND OF THIS TYPE COULD OCCUR THAT WOULD LATER FRACTURE. IN THIS CASE, THE ROOT CAUSE OF THE BEND AND SUBSEQUENT FAILURE DUE TO DUCTILE OVERLOAD IS UNKNOWN, BUT THE ANALYSIS DID NOT SHOW A MANUFACTURING RELATED CAUSE FOR THE ISSUE. IT APPEARS THIS ISSUE WAS NOT PART OF ORIGINAL REPORTED PRODUCT EXPERIENCE. THE LOT HISTORY RECORD WAS REVIEWED AND THERE WERE NO NON-CONFORMITIES ASSOCIATED WITH THIS LOT NUMBER AND PART NUMBER. A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE WAS ONE SIMILAR COMPLAINT REPORTED WITH THIS PART AND LOT NUMBER COMBINATION. THE REPORTED INCIDENT CIRCUMSTANCES WILL BE MONITORED. MANUFACTURING INSPECTS 100% OF THE GUIDE WIRE TIPS AFTER THEY ARE LOADED INTO THE DISPENSER, AND PERFORMS 100% OUTER DIAMETER INSPECTION OF ALL DEVICES PRIOR TO PACKAGING. IN ADDITION, QUALITY CONTROL PERFORMS ON LINE RELIABILITY TESTING AND VERIFIES PRODUCT QUALITY. MANUFACTURING ASSURES THE QUALITY OF THE GUIDE WIRE TIPS THROUGH VISUAL AND DIMENSIONAL INSPECTIONS AND 100% NON-DESTRUCTIVE PULL TEST OF THE TIP. ALSO, SAMPLES ARE DESTRUCTIVELY TESTED TO FAILURE AND EACH LOT MUST PASS THE TEST REQUIREMENTS. QUALITY INSPECTION VERIFIES THAT ALL REQUIREMENTS ARE MET. THIS MDR IS CONSIDERED CLOSED BY THE PRODUCT PERFORMANCE GROUP.

    Description of Event or Problem · 1

    REPORTING STATUS: MALFUNCTION. REPORTING RATIONALE: GUIDE WIRE SEPARATION HAS CAUSED OR CONTRIBUTED TO PATIENT INJURY PREVIOUSLY. DEVICE ISSUE: GUIDE WIRE SEPARATION. IT WAS REPORTED THAT THE GUIDE WIRE WAS FOUND BENT AT THE AREA ALMOST 40 MM FROM THE TIP WHEN UNPACKING. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. THIS IS BEING REPORTED BASED ON THE RETURNED PRODUCT EVALUATION WHICH REVEALED A SEPARATED GUIDE WIRE CORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH HYD DQX ABBOTT VASCULAR-CARDIAC THERAPIES NA 8012682

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK