BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXOR RAABE GUIDING SHEATH

    MDR report key: 1150004 · Received August 27, 2008

    Report

    Report Number
    1820334-2008-00507
    Event Type
    Injury
    Date Received
    August 27, 2008
    Date of Event
    July 29, 2008
    Report Date
    July 31, 2008
    Manufacturer
    COOK, INC.
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PROD WAS RETURNED FOR INVESTIGATION; HOWEVER, WE ARE AWARE OF THE POTENTIAL FOR OCCURRENCE AND ARE CURRENTLY TAKING THE NECESSARY ACTION TO PREVENT THIS TYPE OF COMPLAINT RECURRING. THIS PROD GROUP IS INSPECTED 100% FOR BENDS, KINKS, PROPER SECUREMENT OF PROXIMAL FITTINGS AND OTHER SURFACE IMPERFECTIONS PRIOR TO FURTHER PROCESSING. WE CAN ADVISE THAT FOR ISO STANDARD; FOR SHEATHS 5.0 AND ABOVE THE MINIMUM BREAK FORCE IS 3.37 LB. IN ADDITION, THE PROD LABEL INFORMS THE END USER THAT ALL CATHETERS AND INSTRUMENTS USED WITH THIS PROD SHOULD MOVE FREELY THROUGH THE VALVE SHEATH. SEPARATION OF THE SHEATH MAY RESULT WHEN THE FIT IS TIGHT. NEVERTHELESS, THE APPROPRIATE INDIVIDUALS WERE NOTIFIED OF THIS MATTER AND WILL CONTINUE TO MONITOR FOR SIMILAR REPORTS.

    Description of Event or Problem · 1

    THE SHEATH BROKE WHEN THE PHYSICIAN WAS PASSING A WIRE THROUGH IT, AND BECAME DISLODGED IN THE PT'S BODY. AN OPEN SURGERY OF THE RIGHT GROIN WAS DONE TO RETRIEVE THE DISLODGED SHEATH. NO PIECES OF THE SHEATH WERE LEFT IN THE PT, WHICH WAS VERIFIED VIA X-RAY. ADD'L INFO WAS REC'D ON 08/18/2008: THE EVENT BEGAN WITH A 4FR WHICH WAS LATER UPSIZED TO A 5FR, DIFFERENT WIRE GUIDES WERE ALSO USED DURING THE PROCEDURE. WHEN THE SHEATH UNCOILED AND SEPARATED, A BALLOON WAS PLACED PAST THE RAABE SHEATH AND INFLATED IN ORDER TO RETRIEVE THE PROD. HOWEVER, IT IS BELIEVED THAT WHEN THE PHYSICIAN WAS PULLING BACK ON THE BALLOON, THE DEVICE UNCOILED YET AGAIN, RESULTING IN MORE BREAKAGE. PT OUTCOME IS UNK AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXOR RAABE GUIDING SHEATH DYB INTRODUCER, CATHETER DYB COOK, INC. NA 2103794

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention