BEUDAMED
    FDA Adverse Event Death Summary report: N

    AMPLATZ SUPER STIFF

    MDR report key: 7933555 · Received October 4, 2018

    Report

    Report Number
    3005099803-2018-60685
    Event Type
    Death
    Date Received
    October 4, 2018
    Date of Event
    September 3, 2018
    Report Date
    October 4, 2018
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    EZB
    UDI-DI
    08714729752684
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT'S EXACT AGE IS UNKNOWN; HOWEVER, IT WAS REPORTED THAT THE PATIENT WAS THE OVER THE AGE OF 18. (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AMPLATZ SUPER STIFF UROLOGY GUIDEWIRE WAS USED IN THE SUPERFICIAL FEMORAL ARTERY (SFA) DURING A LOWER EXTREMITY ANGIOGRAM PROCEDURE PERFORMED ON (B)(6) 2018. PER THE DEVICE'S DIRECTIONS FOR USE (DFU) IT STATES THAT THE AMPLATZ UROLOGY GUIDEWIRE IS NOT INTENDED FOR CORONARY OR VASCULAR USE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE AMPLATZ SUPER STIFF UROLOGY GUIDEWIRE AND THE CATHETER (MANUFACTURER UNKNOWN) GOT STUCK. THE AMPLATZ SUPER STIFF UROLOGY GUIDEWIRE BECAME SHREDDED, AND THE TIP OF THE CATHETER BROKE OFF IN THE PATIENT. THE DETACHED PORTION OF THE CATHETER TIP WAS RETRIEVED FROM THE PATIENT. REPORTEDLY, THE CATHETER WAS NOT A BSC PRODUCT. THE PATIENT'S ILIAC ARTERY WAS APPARENTLY TORN, AND THE CAUSE IS UNKNOWN. THE PATIENT BLED OUT AND DIED. IT IS UNKNOWN IF THE DEVICES WERE RELATED TO THE CAUSE OF DEATH. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    776607 AMPLATZ SUPER STIFF STYLET FOR CATHETER, GASTRO-UROLOGY EZB BOSTON SCIENTIFIC CORPORATION M0066401060 0021703689 08714729752684

    Patients

    Seq Age Sex Outcome Treatment
    1 Death