BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSEND EX 014

    MDR report key: 5171602 · Received October 23, 2015

    Report

    Report Number
    3008853977-2015-00438
    Event Type
    Injury
    Date Received
    October 23, 2015
    Date of Event
    July 14, 2015
    Report Date
    October 1, 2015
    Manufacturer
    BOSTON SCIENTIFIC COSTA RICA
    Product Code
    DQX
    PMA / PMN Number
    K934122
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE DEVICE WAS NOT RETURNED FOR ANALYSIS THEREFORE VISUAL INSPECTION AND FUNCTIONAL TESTING COULD NOT BE PERFORMED. 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. INTRACEREBRAL/INTRACRANIAL HEMORRHAGE, STROKE, VESSEL PERFORATION, TRAUMA OR DAMAGE 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

    THE SUBJECT DEVICE WAS DISPOSED BY THE HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN A PTA (PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY) CASE FOR INTRACRANIAL ATHEROSCLEROSIS OF THE RIGHT MIDDLE CEREBRAL ARTERY (MCA), TWO BALLOON CATHETERS WERE USED. DUE TO STIMULATION BY THE PTA, THE VESSEL RECOILED AFTER THE PROCEDURE AND ACUTE OCCLUSION OCCURRED IN THE LESION. IN THE PHYSICIAN'S OPINION, THE BALLOON CATHETERS CAUSED THE OCCLUSION. A STENT WAS REQUIRED TO TREAT THE OCCLUSION. DURING THE PLACEMENT OF THE STENT, THE SUBJECT GUIDEWIRE PERFORATED THE M3 SEGMENT OF THE MCA AND SUBARACHNOID HEMORRHAGE (SAH) WAS NOTED. A HEMATOMA EVACUATION WITH CRANIOTOMY AND EXTERNAL DECOMPRESSION WAS PERFORMED TO TREAT THE SAH. THE PATIENT HAS REPORTEDLY REMAINED IN SEVERE PARALYSIS BUT IS ABLE TO MAKE CONVERSATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN A PTA (PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY) CASE FOR INTRACRANIAL ATHEROSCLEROSIS OF THE RIGHT MIDDLE CEREBRAL ARTERY (MCA), TWO BALLOON CATHETERS WERE USED. DUE TO STIMULATION BY THE PTA, THE VESSEL RECOILED AFTER THE PROCEDURE AND ACUTE OCCLUSION OCCURRED IN THE LESION. IN THE PHYSICIAN'S OPINION, THE BALLOON CATHETERS CAUSED THE OCCLUSION. A STENT WAS REQUIRED TO TREAT THE OCCLUSION. DURING THE PLACEMENT OF THE STENT, THE SUBJECT GUIDEWIRE PERFORATED THE M3 SEGMENT OF THE MCA AND SUBARACHNOID HEMORRHAGE (SAH) WAS NOTED. A HEMATOMA EVACUATION WITH CRANIOTOMY AND EXTERNAL DECOMPRESSION WAS PERFORMED TO TREAT THE SAH. THE PATIENT HAS REPORTEDLY REMAINED IN SEVERE PARALYSIS BUT IS ABLE TO MAKE CONVERSATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702042 TRANSEND EX 014 WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC COSTA RICA 17501092

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other| R