BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_NEUROVASCULAR_PRODUCT

    MDR report key: 4133582 · Received October 1, 2014

    Report

    Report Number
    3008853977-2014-00310
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    January 1, 2014
    Report Date
    September 26, 2014
    Manufacturer
    BOSTON SCIENTIFIC COSTA RICA
    Product Code
    DQX
    PMA / PMN Number
    K022357
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DATE: THE EXACT DATE OF THE EVENT IS UNKNOWN AS IT WAS NOT REPORTED IN THE LITERATURE ARTICLE. THE SUBJECT DEVICE IS NOT AVAILABLE; THEREFORE, ANALYSIS CANNOT BE PERFORMED. FROM THE INFORMATION AVAILABLE, THERE IS NO INDICATION THAT THE REPORTED EVENT IS RELATED TO PRODUCT SPECIFICATIONS NONCONFORMANCE OR MISUSE. THERE IS ALSO NO INDICATION THAT THE SUBJECT DEVICE MALFUNCTIONED. HOWEVER, VASOSPASM, VESSEL PERFORATION, HEMORRHAGE, AND STROKE ARE A KNOWN RISK ASSOCIATED WITH SUCH PROCEDURES AND NOTED AS SUCH IN THE DIRECTIONS FOR USE (DFU). THEREFORE, A ROOT CAUSE OF ANTICIPATED PROCEDURAL COMPLICATION HAS BEEN ASSIGNED TO THE EVENT. THE SUBJECT DEVICE WAS DISPOSED.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A LITERATURE ARTICLE THAT THE PATIENT UNDERWENT AN INTRACRANIAL STENTING PROCEDURE. DURING A CATHETER EXCHANGE PROCEDURE, THE SUBJECT WIRE BECAME TRAPPED AND IMPOSSIBLE TO ADVANCE OR WITHDRAW. ATTEMPTS AT FORCIBLE WITHDRAWAL RETRACTED THE ENTIRE RIGHT CEREBRAL ARTERY, WITHOUT RELEASING THE WIRE. FURTHERMORE, THE M1 TRUNK WAS NOT VISUALIZED ON ANGIOGRAPHY, AND ALL TENSION ON THE MICROWIRE WAS RELEASED. THIS MANEUVER RESTORED MAIN MCA FLOW, BUT THE SUPERIOR DIVISION OF MCA WAS STILL NOT VISUALIZED. WE ASSUMED THAT HYPERACUTE VASOSPASM HAD INTERVENED DUE TO ARTERIAL PERFORATION BY THE MICROGUIDEWIRE. INTRA-ARTERIAL NIMODIPINE (2 MG) WAS SLOWLY INFUSED TO TREAT THE VASOSPASM. HOWEVER, THE GUIDEWIRE REMAINED TRAPPED, EVEN AFTER MICROCATHETER ADVANCEMENT NEARLY TO THE WIRE TIP. ALMOST 2 HOURS ELAPSED BEFORE THE WIRE WAS EVENTUALLY REMOVED. IMMEDIATE POST-PROCEDURAL COMPUTED TOMOGRAPHY (CT) SHOWED DIFFUSE SAH WITH ICH, AND FOLLOW-UP CT SHOWED FRONTAL INFARCTION ATTRIBUTABLE TO THE INJURED FRONTAL BRANCH. THE PATIENT SUFFERED MINOR NEUROLOGIC SEQUELAE, WITH LEFT-SIDED GRADE IV (GLASGOW OUTCOME SCALE 4) WEAKNESS. FOLLOW-UP CONVENTIONAL ANGIOGRAPHY, PERFORMED AT 1 MONTH, AND A MAGNETIC RESONANCE ANGIOGRAM AT 6 MONTHS SHOWED SUSTAINED NARROWING OF THE SUPERIOR DIVISION, WITH THE UNTREATED ANEURYSM UNCHANGED IN SIZE AND CONFIGURATION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613329 UNKNOWN_NEUROVASCULAR_PRODUCT WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC COSTA RICA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other