BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IDC - INTERLOCKING DETACHABLE COIL

    MDR report key: 1012628 · Received March 10, 2008

    Report

    Report Number
    2939204-2008-00077
    Event Type
    Injury
    Date Received
    March 10, 2008
    Date of Event
    February 8, 2008
    Report Date
    February 13, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORK, LTD.
    Product Code
    HCG
    PMA / PMN Number
    EXPORT ONLY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO REGARDING THE ALLEGED EVENT WAS REQUESTED FROM THE USER FACILITY. BASED ON THE INFO PROVIDED, WE WERE ABLE TO DETERMINE THAT THE DEVICES WERE CHECKED PRIOR TO PROCEDURE AND NO ANOMALIES WERE NOTED. NO DIFFICULTIES WERE ENCOUNTERED DURING PREPARATION AND CONTINUOUS FLUSH WAS MAINTAINED. NO MOVEMENT OF THE CATHETER'S TIP WAS NOTED DURING PROCEDURE. NO BLEEDING OF THE FISTULA WAS NOTED PRIOR TO COILING. THE PHYSICIAN WAS MONITORING COIL PLACEMENT UNDER FLUOROSCOPY, HOWEVER HE WAS UNABLE TO SEE THE MARKERS OF THE MICROCATHETER ON EVERY SINGLE COIL PLACEMENT. THE FISTULA WAS APPROXIMATELY BETWEEN 6-8 MM IN SIZE.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A PROCEDURE FOR A CRANIAL DURAL ARTERIAL VENIOUS FISTULA, BOSTON SCIENTIFIC BRAND DETACHABLE COILS WERE IMPLANTED THEN THE FISTULA WAS FILLED AND FINISHED WITH THE INTERLOCKING COILS IN QUESTION. NO PROBLEMS WERE REPORTED DURING THE PROCEDURE AND THE FINAL ANGIOGRAPHIC RESULTS WERE GOOD. SOME HRS (TIME UNSPECIFIED) FOLLOWING THE PROCEDURE, THE PT DEVELOPED A SUBDURAL HEMATOMA IN THE AREA OF THE FISTULA THAT REQUIRED A CRANIOTOMY AND VENTRICLE DRAINAGE TO EVACUATE THE BLOOD AND REDUCE PRESSURE INTO THE BRAIN. THE PT IS REPORTED TO BE IN CRITICAL CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IDC - INTERLOCKING DETACHABLE COIL (HCG) DETACHABLE COIL HCG BOSTON SCIENTIFIC CORK, LTD. 360720 9818932

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention GDC DETACHABLE COILS (MODEL/LOT AND NUMBER OF| COILS USED WAS NOT DISCLOSED).