BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-TORQUE BALANCE MIDDLEWEIGHT ELITE GUIDE WIRE

    MDR report key: 2842955 · Received November 21, 2012

    Report

    Report Number
    2024168-2012-07388
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    October 30, 2012
    Report Date
    October 30, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K103101
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. (B)(4) - EXCESSIVE FORCE. EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE COIL DAMAGE WAS ABLE TO BE CONFIRMED HOWEVER THE RESISTANCE WITH THE SDS WAS UNABLE TO BE CONFIRMED. BASED ON A VISUAL, DIMENSIONAL, AND FUNCTIONAL INSPECTION OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    IT WS REPORTED THAT DURING ABBOTT VASCULAR INTERNAL BENCHTOP TESTING WITH A SYNTHETIC ARTERIAL MODEL, THE BALANCE MIDDLEWEIGHT (BMW) ELITE GUIDE WIRE WAS USED WITH A 3.25 X 38 MM XIENCE XPEDITION STENT DELIVERY SYSTEM (SDS). DURING ATTEMPTED REMOVAL THE BMW ELITE BECAME STUCK IN THE CATHETER AND COULD NOT BE REMOVED. IT REQUIRED 'EXCESSIVE FORCE' TO REMOVE THE GUIDE WIRE FROM THE SDS. THE GUIDE WIRE WAS REMOVED IN ONE PIECE, AND IT WAS NOTED THAT THE COILS ON THE BMW ELITE APPEARED OFFSET. THERE WAS NO PATIENT INVOLVEMENT. THERE WAS NO NOTED ISSUE WITH THE SDS. 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 2060701

    Patients

    Seq Age Sex Outcome Treatment
    1 STENT: XIENCE XPEDITION SDS