BEUDAMED
    FDA Adverse Event Summary report: N

    TRANSEND GUIDEWIRE

    MDR report key: 1082596 · Received July 21, 2008

    Report

    Report Number
    2939204-2008-00293
    Date Received
    July 21, 2008
    Report Date
    July 11, 2008
    Manufacturer
    NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORPROATION
    Product Code
    DQX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER: FOR NO ALLEGATION OF PROD MALFUNCTION OR NON CONFORMANCE.

    Description of Event or Problem · 1

    IT WAS REPORTED AT THE CONFERENCE THAT DURING A PROCEDURE IN 2005 TO TREAT A BASILAR ARTERY TIP ANEURYSM, THE PATIENT SUFFERED A FATAL HEMORRHAGE. THE PHYSICIAN HAD ADVANCED THE GUIDEWIRE [SUBJECT DEVICE] DISTALLY TO THE LESION IN THE P2/P3 SEGMENT AND A STENT WAS SUCCESSFULLY PLACED BRIDGING THE NECK OF THE ANEURYSM. AS THE GUIDEWIRE WAS BEING CAREFULLY MANIPULATED, THE TIP APPEARED TO STRAIGHTEN OUT. ATTEMPTS TO RETRACT THE WIRE WERE UNSUCCESSFUL SUGGESTING THE GUIDEWIRE WAS STUCK IN A SMALL PERFORATOR VESSEL. AN ANGIOGRAM WAS TAKEN BUT SHOWED NO DYE EXTRAVASATION. THE WIRE WAS REMOVED USING A PULL/PUSH TECHNIQUE. THE PATIENT SUFFERED BRADYCARDIA AND EXTRAVASATION WAS NOTED ON ANGIOGRAPHY. COILING WAS PERFORMED TO TREAT THE BLEEDING AND A POST PROCEDURE CT SCAN REVEALED A SIGNIFICANT INTRACRANIAL HEMORRHAGE. TWO DAYS POST PROCEDURE, THE FAMILY REQUESTED THE WITHDRAWAL OF CARE DUE TO NEUROLOGICAL DETERIORATION AND THE PATIENT DIED. THE DATE OF DEATH WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSEND GUIDEWIRE (DCQ) GUIDEWIRE DQX NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORPROATION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death