BEUDAMED
    FDA Adverse Event Death Summary report: N

    TRANSEND EX 014/205 SOFT TIP

    MDR report key: 4031506 · Received August 22, 2014

    Report

    Report Number
    3008853977-2014-00253
    Event Type
    Death
    Date Received
    August 22, 2014
    Date of Event
    August 3, 2014
    Report Date
    August 5, 2014
    Manufacturer
    BOSTON SCIENTIFIC COSTA RICA
    Product Code
    DQX
    PMA / PMN Number
    K931584
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE IS NOT AVAILABLE; THEREFORE, PHYSICAL ANALYSIS CANNOT BE PERFORMED. FROM THE INFORMATION AVAILABLE, THERE IS NO INDICATION THAT THE REPORTED EVENT IS RELATED TO PRODUCT SPECIFICATIONS NONCONFORMANCE OR MISUSE. HOWEVER, VESSEL PERFORATION AND PATIENT OUTCOME OF DEATH ARE KNOWN RISK ASSOCIATED WITH ENDOVASCULAR PROCEDURES AND ARE NOTED AS SUCH IN THE DIRECTIONS FOR USE (DFU).THEREFORE, A ROOT CAUSE OF ANTICIPATED PROCEDURAL COMPLICATIONS HAS BEEN ASSIGNED TO THIS EVENT.

    Additional Manufacturer Narrative · 1

    SUBJECT DEVICE IS NOT AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE, THE GUIDEWIRE'S DISTAL TIP PERFORATED THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY. IN RESPONSE TO THE VESSEL PERFORATION, THE PHYSICIAN SACRIFIED THE M1 SEGMENT BY COILING IT AND SHUTTING DOWN THE VESSEL. IT WAS REPORTED THAT THE PATIENT DIED DUE TO A HEMORRHAGE AS A RESULT OF THE VESSEL PERFORATION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE, THE GUIDEWIRE'S DISTAL TIP PERFORATED THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY. IN RESPONSE TO THE VESSEL PERFORATION, THE PHYSICIAN SACRIFICED THE M1 SEGMENT BY COILING IT AND SHUTTING DOWN THE VESSEL. IT WAS REPORTED THAT THE PATIENT DIED DUE TO A HEMORRHAGE AS A RESULT OF THE VESSEL PERFORATION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    508838 TRANSEND EX 014/205 SOFT TIP WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC COSTA RICA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death| R TRANSFORM BALLOON (STRYKER)