BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSEND¿ EX

    MDR report key: 2578749 · Received May 17, 2012

    Report

    Report Number
    2939204-2012-00126
    Event Type
    Injury
    Date Received
    May 17, 2012
    Date of Event
    March 22, 2012
    Report Date
    May 8, 2012
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    DQX
    PMA / PMN Number
    K944677
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENT ASSISTED ANGIOPLASTY PROCEDURE, THE GUIDEWIRE PERFORATED THE LEFT POSTERIOR CEREBRAL ARTERY. IN RESPONSE TO THE VESSEL PERFORATION, THE PHYSICIAN ADMINISTERED 35MG OF PROTAMINE SULFATE AND 5MG OF VITAMIN K TO REVERSE THE HEPARIN EFFECT. IT WAS REPORTED THAT SUBSEQUENTLY THE PATIENT SUFFERED A STROKE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSEND¿ EX WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - COSTA RICA (COYOL) M001468070

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| O| R IIB/IIIA INHIBITOR (DOSE UNKNOWN)| ASPIRIN (DOSE UNKNOWN)| GATEWAY BALLOON CATHETER (BOSTON SCIENTIFIC)| HEPARIN (DOSE UNKNOWN)| WINGSPAN STENT SYSTEM (BOSTON SCIENTIFIC)| CLOPIDOGREL (DOSE UNKNOWN)