BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-TORQUE BALANCE MIDDLEWEIGHT ELITE GUIDE WIRE

    MDR report key: 2821500 · Received November 6, 2012

    Report

    Report Number
    2024168-2012-06987
    Event Type
    Malfunction
    Date Received
    November 6, 2012
    Date of Event
    October 12, 2012
    Report Date
    October 12, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K103101
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED AND THE REPORTED DIFFICULTIES WERE CONFIRMED VIA RETURNED DEVICE ANALYSIS, AS THE TIP OF THE WIRE WAS STUCK IN THE SIDE HOLE OF THE GUIDING CATHETER AND COULD NOT BE REMOVED INITIALLY. BASED ON VISUAL, DIMENSIONAL AND FUNCTIONAL ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. ADDITIONALLY, A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES WITH THE REPORTED LOT THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT AND A REVIEW OF THE COMPLAINT HISTORY DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    VESSEL BEING TREATED IS THE CIRCUMFLEX.

    Description of Event or Problem · 1

    REPORTEDLY AFTER A NON-ABBOTT GUIDING CATHETER WAS ENGAGED, A BMW ELITE GUIDE WIRE WAS ADVANCED INTO THE GUIDING CATHETER; HOWEVER, THE TIP COILS OF THE GUIDE WIRE WENT INTO A SIDE HOLE OF THE GUIDING CATHETER. ATTEMPTS WERE MADE TO RETRACT THE GUIDE WIRE BUT IT WOULD NOT MOVE AS THE TIP COILS WERE STUCK WITHIN THE SIDE HOLE OF THE GUIDING CATHETER. THE NON-ABBOTT GUIDING CATHETER AND THE BMW ELITE GUIDE WIRE WERE REMOVED OUT OF THE PATIENT ANATOMY IN ONE UNIT AND A NEW GUIDING CATHETER AND GUIDE WIRE WERE USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI-TORQUE BALANCE MIDDLEWEIGHT ELITE GUIDE WIRE GUIDE WIRE DQX AV-TEMECULA-CT 2091101

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE CATHETER: AXESS (JL4.0SH 6FR)