BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSEND EX 014/205 FLOPPY

    MDR report key: 3290924 · Received August 15, 2013

    Report

    Report Number
    3008853977-2013-00289
    Event Type
    Injury
    Date Received
    August 15, 2013
    Date of Event
    January 4, 2012
    Report Date
    July 25, 2013
    Manufacturer
    BOSTON SCIENTIFIC COSTA RICA
    Product Code
    DQX
    PMA / PMN Number
    K944677
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE DEVICE IS NOT AVAILABLE TO THE MANUFACTURE.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT AVAILABLE FOR ANALYSIS. FROM THE INFORMATION PROVIDED THERE WAS NO INDICATION THAT THE DEVICE WAS NOT USED AS IN ACCORDANCE WITH THE LABELING OR THAT THIS CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. REVIEW AND ANALYSIS OF AVAILABLE INFORMATION FAILED TO IDENTIFY A DEFINITIVE CAUSE OF THE REPORTED GUIDEWIRE TIP BREAKAGE; THEREFORE, A CAUSE OF UNDETERMINABLE WAS ASSIGNED TO THE REPORTED GUIDEWIRE TIP SEPARATION. STROKE AND CEREBRAL EDEMA WITH MASS EFFECT ARE KNOWN AND ANTICIPATED COMPLICATIONS TO THESE TYPES OF PROCEDURES AND ARE NOTED IN THE LABELING. THEREFORE, A CAUSE OF ANTICIPATED PROCEDURAL COMPLICATION WAS ASSIGNED TO THE REPORTED STROKE AND ITS COMPLICATIONS.

    Description of Event or Problem · 1

    THE PATIENT PRESENTED WITH A POST-PROCEDURE SUBARACHNOID HEMORRHAGE COMPLICATED BY A VASOSPASM. THE PHYSICIAN INTENDED TO PERFORM AN INTRA-ARTERIAL INFUSION OF VERAPAMIL TO TREAT A VASOSPASM. HOWEVER, DURING THE PROCEDURE THE DISTAL END OF THE GUIDEWIRE BROKE OFF INSIDE THE PATIENT. DURING ATTEMPTS TO RETRIEVE THE BROKEN FRAGMENT, A RIGHT MIDDLE CEREBRAL ARTERY STROKE OCCURRED. SUBSEQUENTLY, THE PATIENT DEVELOPED EDEMA WITH MASS EFFECT AND INCREASED INTRACRANIAL PRESSURE (ICP). THE PATIENT WAS TREATED WITH DECOMPRESSIVE HEMICRANIECTOMY WITH DURAPLASTY TO REDUCE ICP. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    THE PATIENT PRESENTED WITH A POST-PROCEDURE SUBARACHNOID HEMORRHAGE COMPLICATED BY A VASOSPASM.THE PHYSICIAN INTENDED TO PERFORM AN INTRA-ARTERIAL INFUSION OF VERAPAMIL TO TREAT A VASOSPASM. HOWEVER, DURING THE PROCEDURE THE DISTAL END OF THE GUIDEWIRE BROKE OFF INSIDE THE PATIENT. DURING ATTEMPTS TO RETRIEVE THE BROKEN FRAGMENT, A RIGHT MIDDLE CEREBRAL ARTERY STROKE OCCURRED. SUBSEQUENTLY, THE PATIENT DEVELOPED EDEMA WITH MASS EFFECT AND INCREASED INTRACRANIAL PRESSURE (ICP). THE PATIENT WAS TREATED WITH DECOMPRESSIVE HEMICRANIECTOMY WITH DURAPLASTY TO REDUCE ICP. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394868 TRANSEND EX 014/205 FLOPPY WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC COSTA RICA

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention SL-10 EXCELSIOR MICROCATHETER (STRYKER)