BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMPLATZ SUPER STIFF GUIDEWIRE

    MDR report key: 3073130 · Received April 23, 2013

    Report

    Report Number
    2134265-2013-02503
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    March 22, 2013
    Report Date
    July 9, 2013
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    DQX
    PMA / PMN Number
    K843012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER - 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

    IT WAS FURTHER REPORTED THAT THE REPORTED AMPLATZ WIRE WAS NOT A BSC MANUFACTURED DEVICE.

    Description of Event or Problem · 1

    SAME CASE AS MFR ID # 2134265-2013-02504. IT WAS REPORTED THAT DURING A ANGIOPLASTY PROCEDURE, THE STENT DELIVERY SYSTEM BECAME STUCK ON THE GUIDEWIRE. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA), WITH TORTUOSITY NOTED AS "NOT EXTENSIVE". AS THE 6MMX150MM 130CM INNOVA STENT WAS ADVANCED ON THE AMPLATZ WIRE THE DEVICE BECAME STUCK AND COULD NOT BE ADVANCED OR WITHDRAWN ON THE WIRE. THE INNOVA AND AMPLATZ DEVICES WERE REMOVED TOGETHER AS A UNIT. THE PROCEDURE WAS COMPLETED WITH TWO EPIC STENTS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175496 AMPLATZ SUPER STIFF GUIDEWIRE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - COSTA RICA (COYOL) UNK531

    Patients

    Seq Age Sex Outcome Treatment
    1