BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PT²?

    MDR report key: 3190528 · Received June 26, 2013

    Report

    Report Number
    2134265-2013-04379
    Event Type
    Injury
    Date Received
    June 26, 2013
    Date of Event
    February 14, 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 COMPLAINT DEVICE WAS NOT RECEIVED FOR ANALYSIS THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE MOST PROBABLE ROOT CAUSE WAS UNABLE TO BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS USER FACILITY MEDWATCH #: 3901620000-2013-8001. IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE, GUIDEWIRE FRACTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT SUPERFICIAL FEMORAL ARTERY. A 300 CM STR PT GUIDEWIRE WAS ADVANCED. THE TIP OF THE INTERVENTIONAL WIRE BROKE OFF IN THE LEFT SUPERFICIAL FEMORAL ARTERY. THE PROCEDURE ITSELF WAS NOT SUCCESSFUL SINCE THE TIP OF THE WIRE REMAINED INSIDE THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291277 PT²? WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - COSTA RICA (COYOL) H74938931040

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other