BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSEND 300 GUIDEWIRE

    MDR report key: 1001943 · Received February 20, 2008

    Report

    Report Number
    2939204-2008-00048
    Event Type
    Injury
    Date Received
    February 20, 2008
    Date of Event
    January 22, 2008
    Report Date
    January 22, 2008
    Manufacturer
    NEUROVASCULAR, A DIV OF BOSTON SCIENTIFIC CORP
    Product Code
    DQX
    PMA / PMN Number
    K022357
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO APPARENT DEVICE FAILURE, AS THE USER DID NOT ALLEGE ANY DEFICIENCIES WITH THIS DEVICE. FOLLOW UP RESPONSES FROM THE USER STATE THAT THE PHYSICIAN DOES NOT ALLEGE THAT THE GUIDEWIRE OR PROCEDURES/DEVICES USED PRIOR CAUSED THE BLEED, AS THE PHYSICIAN IS UNSURE OF THE SOURCE OF THE BLEED. THE RISK OF THE REPORTED EVENT IS CONTAINED IN THE DEVICE DIRECTIONS FOR USE (DFU). PER THE DFU: "POTENTIAL ADVERSE EVENTS ASSOCIATED WITH ENDOVASCULAR PROCEDURES (INCLUDING GUIDE WIRE USAGE IN THE NEURO AND PERIPHERAL VASCULATURE) INCLUDE BUT ARE NOT LIMITED TO: ANEURYM RUPTURE; ACCESS SITE COMPLICATIONS INCLUDING INFECTION, HEMATOMA, AND NERVE INJURY; CEREBRAL ISCHEMIA; DEATH; EMBOLISM (CATHETER/DEVICE, AIR BUBBLE, PLAQUE, THROMBUS OR CHAR); INTRACEREBRAL/INTRACRANIAL HEMORRHAGE; PSEUDOANEURYSM; SEIZURE; STROKE; TRANSIENT ISCHEMIA ATTACK; VASOSPASM; AND VESSEL PERFORATION, DISSECTION, TRAUMA OR DAMAGE." BASED ON THE INFO KNOWN AT THIS TIME, BOSTON SCIENTIFIC CANNOT CONCLUSIVELY DETERMINE THE CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED IN 2008, A STENT ASSISTED ANEURYSM COILING PROCEDURE OF THE ACI (ARTERY, CAROTIS INTERNAL). A "YOUNG MALE PT WITH A RUPTURED ACI ANEURYSM WITH NECK WAS TREATED WITH..." 2 STENTS, BOTH OF WHICH COULD NOT BE DEPLOYED IN THE TORTUOUS ANATOMY. THE PT, ON A HIGH AMOUNT OF ANTICOAGULANTS, WAS TREATED ONLY WITH COILS. DURING MANIPULATION OF THE PREVIOUSLY SHAPED SUBJECT DEVICE (GUIDEWIRE), A SMALL BLEED WAS NOTED. THE PHYSICIAN IS UNSURE OF THE SOURCE OF THE BLEED. THE BLEED WAS NOTED IN A POST PROCEDURE CT (COMPUTED TOMOGRAPHY), NOT DURING THE PROCEDURE. THE PT WAS "...GETTING WELL AT THE MOMENT WITH SMALL BLEEDING." THE FOLLOWING DAY, INTRACRANIAL PRESSURE WAS RELIEVED, AND "...THE PT IS STABLE..." TWO DAYS LATER. DURING THESE TREATMENTS, A PERFORATION AND BLEEDING SOURCE COULD NOT BE FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSEND 300 GUIDEWIRE DQX - WIRE, GUIDE, CATHETER DQX NEUROVASCULAR, A DIV OF BOSTON SCIENTIFIC CORP

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other NEUROFORM STENT