BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING

    MDR report key: 3132672 · Received May 29, 2013

    Report

    Report Number
    2024168-2013-03306
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    May 2, 2013
    Report Date
    May 3, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K013833
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. 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 WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING ARTERY WITH HEAVY TORTUOSITY. THE FIRST BALANCE MIDDLEWEIGHT (BMW) GUIDE WIRE WAS ADVANCED AND CROSSED THE LESION, BUT MET RESISTANCE WITH THE ANATOMY DISTALLY. A BALLOON CATHETER WAS ADVANCED, BUT THERE WAS NOT ENOUGH SUPPORT AND THE BALLOON CATHETER WAS REMOVED WITHOUT ISSUE. THE BMW GUIDE WIRE WAS LEFT IN THE ANATOMY FOR FUTURE DEVICE ADVANCEMENT. A SECOND BMW GUIDE WIRE WAS ADVANCED, BUT COULD NOT CROSS TO THE LESION, AND WAS REMOVED. AN EXTRA SPORT GUIDE WIRE WAS USED SUCCESSFULLY. DILATATION WAS PERFORMED AND A STENT POSITIONED AT THE LESION. BEFORE INFLATING THE STENT DELIVERY SYSTEM, THE BMW GUIDE WIRE WAS ATTEMPTED TO BE REMOVED, BUT THE GUIDE WIRE SEPARATED. THERE WAS NO RESISTANCE NOTED DURING REMOVAL. THREE XIENCE V STENTS WERE IMPLANTED TO COMPRESS THE SEPARATED PORTION OF GUIDE WIRE TO THE VESSEL WALL. IT WAS NOTED THAT A VERY THIN FILAMENT OF THE SEPARATED PORTION IS FLUCTUATING IN THE AORTA. THE PATIENT IS REPORTED TO BE FINE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234697 ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING GUIDE WIRE DQX AV-TEMECULA-CT 2112771

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention