BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASAHI GRANDSLAM PTCA GUIDE WIRE

    MDR report key: 2001910 · Received February 27, 2011

    Report

    Report Number
    3003775027-2011-00006
    Event Type
    Injury
    Date Received
    February 27, 2011
    Date of Event
    January 28, 2011
    Report Date
    February 3, 2011
    Manufacturer
    AV-ASAHI
    Product Code
    DQX
    PMA / PMN Number
    K031277
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    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. THE DEVICE IS MANUFACTURED BY ASAHI INTECC. CO. LTD. MEDICAL DIVISION; HOWEVER, ABBOTT VASCULAR DISTRIBUTES THE DEVICE AND IS RESPONSIBLE FOR MDR REPORTING. THOUGH DEVICE INVESTIGATION COULD NOT BE CONDUCTED BECAUSE IT WAS NOT RETURNED, WE PRESUME AND CONSIDER FROM THE PROVIDED INFORMATION THAT THE GUIDEWIRE TIP WAS TRAPPED BY THE CALCIFIED LESION OR SOME OTHER FACTOR, WHERE THE PULL-BACK MANIPULATION TO THE GUIDEWIRE WAS APPLIED, RESULTING THE GUIDEWIRE BREAKAGE DUE TO THE FORCE EXCEEDING THE PRODUCT DESIGN LIMIT. WARNING SECTION OF THE INSTRUCTION FOR USE (IFU) STATES; IF ANY RESISTANCE IS FELT DUE TO SPASM OR THE GUIDEWIRE BEING BENT OR TRAPPED WHILE OPERATING THE GUIDEWIRE IN THE BLOOD VESSEL OR REMOVING IT, NOT MOVE OR TORQUE THE GUIDEWIRE. STOP THE PROCEDURE. DETERMINE THE CAUSE OF RESISTANCE UNDER FLUOROSCOPY AND TAKE APPROPRIATE REMEDIAL ACTION. IF THE GUIDEWIRE IS MOVED EXCESSIVELY IT MAY BREAK OR BECOME DAMAGED, ... RESULT IN FRAGMENTS BEING LEFT INSIDE THE VESSEL AND SEPARATION OR BREAKAGE OF GUIDEWIRE AS ONE OF THE POSSIBLE COMPLICATIONS AND ADVERSE EVENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, IN A MODERATE TO HEAVILY CALCIFIED OBTUSE MARGINAL ARTERY, WHILE REMOVING THE GRAND SLAM 190MM WIRE, THE TIP BROKE OFF IN THE BODY. RESISTANCE WAS FELT AT THE TIME THAT THE TIP BROKE OFF. THE TIP WAS SUCCESSFULLY RETRIEVED. THE CASE WAS EXTENDED BY 20 MINUTES DUE TO THE BREAKAGE AND REMOVAL OF THE TIP. THERE WAS NO ADVERSE PATIENT SEQUELA. ALTHOUGH REQUESTED, THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASAHI GRANDSLAM PTCA GUIDE WIRE GUIDE WIRE DQX AV-ASAHI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention