BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PT²?

    MDR report key: 3190540 · Received June 26, 2013

    Report

    Report Number
    2134265-2013-04378
    Event Type
    Injury
    Date Received
    June 26, 2013
    Date of Event
    February 28, 2013
    Report Date
    May 29, 2013
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    DQX
    PMA / PMN Number
    K030617
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS USER FACILITY MEDWATCH # 3901620000-2013-8002. IT WAS REPORTED THAT DURING A PERIPHERAL ANGIOPLASTY TREATMENT PROCEDURE, GUIDEWIRE FRACTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE RIGHT LOWER EXTREMITY ARTERY. A 300CM PT2 GUIDEWIRE WAS BEING ADVANCED TO THE LESION AND THEY NOTICED THE WIRE WAS BENT CAUSING DELAMINATION. UPON REMOVING THE WIRE THEY NOTICED THAT 3-4MM OF THE TIP WAS MISSING. THE PATIENT DID NOT REQUIRE SURGICAL REMOVAL AS THE VESSEL WAS TOTALLY OCCLUDED. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291278 PT²? WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - COSTA RICA (COYOL) H74938931040

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other