BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXOR ANSEL GUIDING SHEATH

    MDR report key: 1903530 · Received November 19, 2010

    Report

    Report Number
    1820334-2010-00608
    Event Type
    Injury
    Date Received
    November 19, 2010
    Report Date
    October 18, 2010
    Manufacturer
    COOK, INC.
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MANUFACTURE DATE: UNK AS LOT IS UNK. ADDITIONAL INFORMATION: NO PRODUCT WAS RETURNED TO ASSIST IN THIS INVESTIGATION. EACH DEVICE IS 100% INSPECTED TO CONFIRM (B)(4). WITHOUT BENEFIT OF INSPECTING THE COMPLAINT DEVICE, THE COMPLAINT IS CONFIRMED SOLELY ON THE REPORTED STATEMENTS OF THE EVENT. RELEVANT TO THIS FAILURE MODE OF HUB SEPARATION, A REVIEW OF OUR FILES SHOWS THAT THIS DEVICE WAS MANUFACTURED AFTER THE IMPLEMENTATION OF ACTION ACTIVITIES ON 06/27/2008. WE ARE CONTINUING OUR MONITORING OF COMPLAINTS FOR SIMILAR EVENTS AND HAVE NOTIFIED THE APPROPRIATE INTERNAL PERSONNEL OF THIS EVENT.

    Description of Event or Problem · 1

    PHYSICIAN PERFORMED ANGIOPLASTY ON A PATIENT. AT THE END OF PROCEDURE, PHYSICIAN EXPERIENCED A LOT OF RESISTANCE DURING INTRODUCER REMOVAL. DURING INTRODUCER REMOVAL, INTRODUCER'S VALVE CAME OFF THE SHEATH. THE PHYSICIAN HAD TO CLOSE SHEATH WITH FORCEPS IN ORDER TO REDUCE BLOOD LOSS AND, AFTER MANY EFFORTS, HE WAS NOT ABLE TO REMOVE THE SHEATH FROM THE PATIENT. PATIENT OUTCOME WAS NOT PROVIDED BY REPORTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXOR ANSEL GUIDING SHEATH DYB INTRODUCER, CATHETER DYB COOK, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization