BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXOR SHUTTLE GUIDING SHEATH

    MDR report key: 5839785 · Received August 2, 2016

    Report

    Report Number
    1820334-2016-00817
    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

    EVALUATION- IT IS NOTED THAT THE COMPLAINT DEVICE IS A 6F FLEXOR SHUTTLE GUIDING SHEATH THAT WAS NOT RETURNED FOR EVALUATION. 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. 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 6F SHUTTLE, DIGITAL ACCESS CATHETER 057, OR THE MICRO CATHETER. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED AND WE WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Additional Manufacturer Narrative · 1

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

    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 #3, PRESENTED WITH INCIDENTAL BILATERAL PERIOPHTHALMIC ANEURYSMS, TREATED 4 WEEKS APART BY COIL-SUP- PORTED PIPELINE EMBOLIZATION USING SINGLE-GROIN ACCESS, WITH SE-QUENTIAL DEPLOYMENT OF COILS AND THE PIPELINE DEVICE, THE LATTER THROUGH A TRIAXIAL SYSTEM OF STRYKER 6F SHUTTLE, DAC 057 AND MARKSMAN CATHETERS. PERSISTENT DAILY HEADACHES DEVELOPED 2 WEEKS LATER; MR IMAGING PERFORMED 2 MONTHS POSTEMBOLIZATION SHOWED BILATERAL PREDOMINANTLY SUB-CORTICAL ENHANCING LESIONS, IN THIS CASE WITH LITTLE EDEMA AND NO SUSCEPTIBILITY ARTIFACTS. FINDINGS OF EXTENSIVE RHEUMATOLOGIC AND INFECTIOUS EVALUATIONS WERE NEGATIVE. NO TREATMENT WAS UNDERTAKEN. TWO FOLLOW-UP MRIS DURING 18 MONTHS SHOWED AN INCREASE IN THE NUMBER AND SIZE OF THE LESIONS. A SIX-WEEK COURSE OF CORTICOSTEROIDS HAD MINIMAL EFFECT ON BASELINE MILD EDEMA OR DAILY HEADACHES. BIOPSY OF THE LEFT FRONTAL LOBE SHOWED GIANT CELL GRANULOMAS AND REACTIVE GLIOSIS SURROUNDING FOREIGN BODY MATERIAL WITH STAINING CHARACTERISTICS IDENTICAL TO THOSE OF A PVP COATING. A MORE DELAYED MR IMAGING 3 MONTHS POST-STEROID TAPER SHOWED A DECREASE IN THE NUMBER AND SIZE OF ENHANCING NODULES. PATIENT SURVEILLANCE IS REPORTED AS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492167 FLEXOR SHUTTLE GUIDING SHEATH DYB INTRODUCER, CATHETER DYB COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening