BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNCHRO GUIDEWIRE

    MDR report key: 1779104 · Received August 2, 2010

    Report

    Report Number
    2939204-2010-00833
    Event Type
    Death
    Date Received
    August 2, 2010
    Date of Event
    August 7, 2007
    Report Date
    July 14, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SALT LAKE CITY
    Product Code
    DQX
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PMA# OR 510K#: K032146; K002907; K023700 AND K053268. CONCLUSION: FOR ANTICIPATED PROCEDURAL COMPLICATION. 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. ANEURYSM RUPTURE AND DEATH ARE KNOWN AND ANTICIPATED COMPLICATIONS TO THESE TYPES OF PROCEDURES AND ARE NOTED IN THE LABELING. THEREFORE, IT WAS DETERMINED THAT THE REPORTED EVENT WAS AN ANTICIPATED PROCEDURAL COMPLICATION.

    Additional Manufacturer Narrative · 1

    PMA# OR 510K#: K032146; K002907; K023700 AND K053268

    Description of Event or Problem · 1

    THE MICROCATHETER AND BALLOON CATHETER WERE UNEVENTFULLY PLACED AT THE NECK OF THE LEFT POSTERIOR COMMUNICATING ARTERY (PCOM) ANEURYSM. FOLLOWING THE SUCCESSFUL TEST INFLATION OF THE BALLOON CATHETER, THE GUIDEWIRE WAS REMOVED. SHORTLY AFTERWARDS, THE PATIENT BECAME ACUTELY HYPERTENSIVE AND BRADYCARDIC. THE IMAGING REVEALED A DIFFUSE SPASM OF THE LEFT INTERNAL CAROTID ARTERY (ICA) AND EXTRAVASATION ALONG THE INFERIOR POSTERIOR ASPECT OF THE ANEURYSM. HEPARIN HAD BEEN REVERSED WITH PROTAMINE SULFATE. THE COIL EMBOLIZATION PROCEDURE WAS ABORTED. AN EMERGENT ANEURYSM CLIPPING SURGERY WITH CRANIOTOMY AND DUROTOMY WAS PERFORMED. INTERMITTENT BALLOON INFLATION AND DEFLATION WAS USED BETWEEN THE ANGIOGRAM AND CRANIOTOMY TO CONTROL HEMORRHAGE AND TO IMPROVE CEREBRAL PERFUSION. POST PROCEDURES, THE PATIENT SUFFERED A PERMANENT BRAIN INJURY. THE PATIENT SUBSEQUENTLY EXPIRED; THE CAUSE OF DEATH WAS NOT DISCLOSED.

    Description of Event or Problem · 1

    THE MICROCATHETER AND BALLOON CATHETER WERE UNEVENTFULLY PLACED AT THE NECK OF THE LEFT POSTERIOR COMMUNICATING ARTERY (PCOM) ANEURYSM. FOLLOWING THE SUCCESSFUL TEST INFLATION OF THE BALLOON CATHETER, THE GUIDEWIRE WAS REMOVED. SHORTLY AFTERWARDS, THE PATIENT BECAME ACUTELY HYPERTENSIVE AND BRADYCARDIC. THE IMAGING REVEALED A DIFFUSE SPASM OF THE LEFT INTERNAL CAROTID ARTERY (ICA) AND EXTRAVASATION ALONG THE INFERIOR POSTERIOR ASPECT OF THE ANEURYSM. HEPARIN HAD BEEN REVERSED WITH PROTAMINE SULFATE. THE COIL EMBOLIZATION PROCEDURE WAS ABORTED. AN EMERGENT ANEURYSM CLIPPING SURGERY WITH CRANIOTOMY AND DUROTOMY WAS PERFORMED. INTERMITTENT BALLOON INFLATION AND DEFLATION WAS USED BETWEEN THE ANGIOGRAM AND CRANIOTOMY TO CONTROL HEMORRHAGE AND TO IMPROVE CEREBRAL PERFUSION. POST PROCEDURES THE PATIENT SUFFERED A PERMANENT BRAIN INJURY. THE PATIENT SUBSEQUENTLY EXPIRED; THE CAUSE OF DEATH WAS NOT DISCLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRO GUIDEWIRE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - SALT LAKE CITY UNK174

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Death| O| R HYPERFORM BALLOON (EV3)| EXCELSIOR MICROCATHETER(BOSTON SCIENTIFIC)| HEPARIN (DOSAGE UNKNOWN)