BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXOR SHUTTLE GUIDING SHEATH

    MDR report key: 5839331 · Received August 2, 2016

    Report

    Report Number
    1820334-2016-00816
    Event Type
    Injury
    Date Received
    August 2, 2016
    Report Date
    April 12, 2017
    Manufacturer
    COOK INC
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD AND SEARCH FOR SIMILAR COMPLAINTS FROM THE COMPLAINT LOT COULD NOT BE PERFORMED SINCE THE LOT NUMBER IS UNKNOWN. PER THE INVESTIGATOR'S EVALUATION, "DUE TO THE LIMITED AVAILABLE INFORMATION, IT IS NOT CLEAR IF THE ROOT CAUSE OF THE EVENT IS ASSOCIATED WITH THE PATIENT'S CONDITION, THE MEDICAL PROCEDURE, OR AN EVENTUAL MALFUNCTION OF THE 5F SHUTTLE, OR THE COMPETITOR'S DEVICES." WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION. (B)(4).

    Description of Event or Problem · 1

    JOURNAL ARTICLE: M. SHAPIRO, M.D., ET AL: FOREIGN BODY EMBOLI FOLLOWING CEREBROVASCULAR INTERVENTIONS: CLINICAL, RADIOGRAPHIC, AND HISTOPATHOLOGIC FEATURES. AJNR AM J NEURORADIOL 36:2121-26 NOV 2015. THE ABOVE REFERENCED JOURNAL ARTICLE ALLEGED THAT A PATIENT, IDENTIFIED AS PATIENT #1, UNDERWENT UNREMARKABLE COIL-SUPPORTED PIPELINE EMBOLIZATION OF AN INCIDENTAL RIGHT TRIGEMINAL ANEURYSM USING DUAL-GROIN ACCESS; THE PIPELINE DEPLOYMENT AXIS CONSISTED OF COOK 5F SHUTTLE, COVIDIEN NAVIEN 058 AND COVIDIEN MARKSMAN CATHETERS. THE PATIENT FELT PERSISTENTLY TIRED DURING THE SUBSEQUENT 8 WEEKS, FOLLOWED BY DEVELOPMENT OF LEFT-SIDED WEAKNESS AND LEFT HOMONYMOUS QUADRANTANOPSIA. CT SHOWED MULTIFOCAL RIGHT-HEMISPHERE EDEMA. MR IMAGING DEMONSTRATED MULTIPLE SUBCENTIMETER LESIONS, PREDOMINANTLY WITHIN THE SUBCORTICAL WHITE MATTER AND AT THE GRAY-WHITE JUNCTIONS. MOST LESIONS SHOWED BOTH MAGNETIC SUSCEPTIBILITY AND ENHANCEMENT. NONE HAD RESTRICTED DIFFUSION, AND ALL WERE SURROUNDED BY EXTENSIVE VASOGENIC EDEMA. EMPIRIC 6-WEEK ANTIBIOTIC TREATMENT WAS UNDERTAKEN CONCURRENTLY WITH A 2-MONTH COURSE OF DEXAMETHASONE. ALL NEUROLOGIC SYMPTOMS RESOLVED IN 4 WEEKS. SERIAL MR IMAGING SHOWED NEAR-RESOLUTION OF THE EDEMA. ALL LESIONS CONTINUE TO ENHANCE. CURRENTLY, THE EXTENT OF MAGNETIC SUSCEPTIBILITY IS UNCHANGED, AND NO NEW LESIONS HAVE DEVELOPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493188 FLEXOR SHUTTLE GUIDING SHEATH DYB INTRODUCER, CATHETER DYB COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening