BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHRO GUIDEWIRE

    MDR report key: 1660041 · Received April 15, 2010

    Report

    Report Number
    2939204-2010-00634
    Event Type
    Injury
    Date Received
    April 15, 2010
    Date of Event
    March 22, 2010
    Report Date
    March 25, 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.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT AVAILABLE FOR EVALUATION. 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. VESSEL PERFORATION IS A KNOWN AND ANTICIPATED COMPLICATION TO THESE TYPES OF PROCEDURES AND IS NOTED IN THE LABELING. THE MOST LIKELY THAT SOME ANATOMICAL OR PROCEDURAL FACTORS CAUSED OR CONTRIBUTED TO THE EVENT. THEREFORE, A ROOT CAUSE RELATED TO OPERATIONAL CONTEXT HAS BEEN ASSIGNED TO THIS EVENT.

    Description of Event or Problem · 1

    THE PHYSICIAN USED TWO GUIDEWIRES DURING A STENT ASSISTED EMBOLIZATION FOR THE REOCCURRENCE OF THE BASILAR TIP ANEURYSM. FOLLOWING ADVANCEMENT OF THE MICROCATHETER OVER THE GUIDEWIRE, THE IMAGING REVEALED EXTRAVASATION FROM THE LEFT POSTERIOR TEMPORAL ARTERY DUE TO THE VESSEL PERFORATION. THE PHYSICIAN STATED THAT THE MOST PROBABLE CAUSE OF THE VESSEL PERFORATION WAS A GUIDEWIRE; HOWEVER, HE IS NOT SURE WHICH GUIDEWIRE CONTRIBUTED TO THE VESSEL PERFORATION. SUBSEQUENTLY, THE PATIENT SUFFERED A SUBARACHNOID HEMORRHAGE (SAH) IN THE LEFT TEMPORAL LOBE AND INTRAVENTRICULAR HEMORRHAGE. A RIGHT FRONTAL VENTRICULOSTOMY WAS PERFORMED TO REDUCE THE INTRACRANIAL PRESSURE AND FIVE PACKS OF PLATELETS WERE GIVEN. HOWEVER, THE PATIENT CONTINUED TO DECLINE. IMAGING SHOWED A SIGNIFICANT INCREASE IN THE SIZE OF THE HEMORRHAGE AND THE VENTRICLES AND REVEALED A MIDLINE SHIFT OF THE BRAIN. ONE DAY POST PROCEDURE, THE PATIENT UNDERWENT A SECOND CRANIOTOMY THIS TIME IN THE LEFT PARIETAL REGION DURING WHICH CLOT WAS REMOVED AND A SECOND EXTERNAL VENTRICULAR DRAIN WAS PLACED TO ASSIST IN CONTROLLING INTRACRANIAL PRESSURE. THREE DAYS POST PROCEDURE, THE PATIENT SUFFERED ASPIRATION PNEUMONIA WITH RESPIRATORY FAILURE THAT WAS TREATED WITH ANTIBIOTICS. THE PATIENT'S CURRENT CONDITION WAS REPORTED AS ¿ALIVE, WITH RIGHT SIDED WEAKNESS¿.

    Description of Event or Problem · 1

    THE PHYSICIAN USED TWO GUIDEWIRES DURING A STENT ASSISTED EMBOLIZATION FOR THE REOCCURRENCE OF THE BASILAR TIP ANEURYSM. FOLLOWING ADVANCEMENT OF THE MICROCATHETER OVER THE GUIDEWIRE, THE IMAGING REVEALED EXTRAVASATION FROM THE LEFT POSTERIOR TEMPORAL ARTERY DUE TO THE VESSEL PERFORATION. THE PHYSICIAN STATED THAT THE MOST PROBABLE CAUSE OF THE VESSEL PERFORATION WAS A GUIDEWIRE; HOWEVER, HE IS NOT SURE WHICH GUIDEWIRE CONTRIBUTED TO THE VESSEL PERFORATION. SUBSEQUENTLY, THE PATIENT SUFFERED A SUBARACHNOID HEMORRHAGE (SAH) IN THE LEFT TEMPORAL LOBE AND INTRAVENTRICULAR HEMORRHAGE. A RIGHT FRONTAL VENTRICULOSTOMY WAS PERFORMED TO REDUCE THE INTRACRANIAL PRESSURE AND FIVE PACKS OF PLATELETS WERE GIVEN. HOWEVER, THE PATIENT CONTINUED TO DECLINE. IMAGING SHOWED A SIGNIFICANT INCREASE IN THE SIZE OF THE HEMORRHAGE AND THE VENTRICLES AND REVEALED A MIDLINE SHIFT OF THE BRAIN. ONE DAY POST PROCEDURE, THE PATIENT UNDERWENT A SECOND CRANIOTOMY THIS TIME IN THE LEFT PARIETAL REGION DURING WHICH CLOT WAS REMOVED AND A SECOND EXTERNAL VENTRICULAR DRAIN WAS PLACED TO ASSIST IN CONTROLLING INTRACRANIAL PRESSURE. THREE DAYS POST PROCEDURE THE PATIENT SUFFERED ASPIRATION PNEUMONIA WITH RESPIRATORY FAILURE THAT WAS TREATED WITH ANTIBIOTICS. THE PATIENTS¿ CURRENT CONDITION WAS REPORTED AS ¿ALIVE, WITH RIGHT SIDED WEAKNESS¿.

    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 66 YR Other| R TRANSEND 14 GUIDEWIRE (BOSTON SCIENTIFIC)| SEVEN THOUSAND UNITS OF HEPARIN| EXCELSIOR SL-10 MICROCATHETER (BOSTON SCIENTIFIC)