BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-TORQUE BALANCE MIDDLEWIEGHT UNIVERSAL II GUIDE WIRE

    MDR report key: 1790291 · Received August 6, 2010

    Report

    Report Number
    2024168-2010-01629
    Event Type
    Malfunction
    Date Received
    August 6, 2010
    Date of Event
    July 14, 2010
    Report Date
    July 15, 2010
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES-P.R.
    Product Code
    DQX
    PMA / PMN Number
    K072460
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE.

    Description of Event or Problem · 1

    DEVICE ISSUE: PEELING OF COATING. TIME OF DEVICE ISSUE: DURING THE PROCEDURE. ADVERSE EVENT: NONE. IT WAS REPORTED THAT THE GUIDE WIRE WAS INITIALLY USED IN THE LEFT ANTERIOR DESCENDING ARTERY WITH NO ISSUE. IT WAS REMOVED AND APPEARED OK. IT WAS USED A SECOND TIME IN THE RIGHT CORONARY ARTERY, BUT A DILATATION CATHETER, RX VOYAGER GOT "HUNG UP" NEAR COMPLETION WITH THE DISTAL RADIOPAQUE MARKERS. WHEN THE GUIDE WIRE WAS REMOVED IT APPEARED THAT THE HYDROPHILIC COATING WAS STRIPPED. A SECOND GUIDE WIRE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PT EFFECTS. NO ADD'L INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI-TORQUE BALANCE MIDDLEWIEGHT UNIVERSAL II GUIDE WIRE DQX ABBOTT VASCULAR-CARDIAC THERAPIES-P.R. NA 0052072

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR DIL CATH: VOYAGER