BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEEL AWAY & SPLIT SHEATH PERCU CATH INTRODUCER

    MDR report key: 1560543 · Received December 14, 2009

    Report

    Report Number
    3006945290-2009-00004
    Event Type
    Injury
    Date Received
    December 14, 2009
    Date of Event
    October 30, 2009
    Report Date
    November 12, 2009
    Manufacturer
    TELEFLEX, INC.
    Product Code
    DYB
    PMA / PMN Number
    K091491
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    TELEFLEX, THE SUPPLIER OF THE PEEL-AWAY SHEATH WAS NOTIFIED OF THE EVENT. THEY INDICATED THEY HAVE NOT HAD ANY REPORTS OF THIS TYPE OF FAILURE. THIS IS A STANDARD SHEATH USED ROUTINELY IN MANY ENDOVASCULAR PROCEDURES. WE CONDUCTED TESTING ON SAMPLE OF REP PRODUCT FROM THE SAME MFR. IN ATTEMPTING TO RECREATE THE FAILURE, COMPONENTS WERE SUBJECTED TO EXTREME CONDITIONS (STRETCHING, KINKING, PINCHING) NONE OF WHICH REPRODUCED A SIMILAR FAILURE TO THAT EXPERIENCED IN THE IMPLANT PROCEDURE. REPEATED CYCLING OF THE SHEATH UNDER THE ABOVE EXTREME CONDITIONS ALSO DID NOT CAUSE SEPARATION FRACTURE OF THE SHEATH MATERIAL. THE ONLY MEANS FOR REPRODUCING THE FAILURE DESCRIBED WAS BY CUTTING OR PIERCING THE SHEATH WITH A SHARP INSTRUMENT PRIOR TO PULLING/STRETCHING THE SHEATH COMPONENT. THE TYPE OF DAMAGE (CUTTING/PIERCING) WOULD HAVE BEEN CAUSED BY MISUSE.

    Description of Event or Problem · 1

    DURING THE PLACEMENT OF A HERO DIALYSIS ACCESS DEVICE INTO THE RIGHT INTERNAL JUGULAR VEIN OF A PT, A TELEFLEX STANDARD PEEL AWAY SHEATH BEING USED BY THE VASCULAR INTERVENTIONAL RADIOLOGIST TORE RESULTING IN BLEEDING. A CARDIOTHORACIC SURGEON WAS CALLED TO THE ROOM, EMERGENCY RELEASE BLOOD WAS ORDERED AND IV FLUIDS WERE ADMINISTERED. THE SURGEONS WERE ABLE TO RETRIEVE THE 5 CM PIECE OF TELEFLEX SHEATH REMAINING IN THE VEIN BY ENLARGING THE INCISION AT THE SITE AND USING A KELLY CLAMP. NO FURTHER INTERVENTION WAS NEEDED ONCE IT WAS REMOVED. THE SURGEONS BELIEVE THE INCIDENT WAS CONTROLLED AND NO FURTHER EXTRAORDINARY MEASURES WERE NEEDED. THE PT WAS RELEASED TO PACU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PEEL AWAY & SPLIT SHEATH PERCU CATH INTRODUCER DYB TELEFLEX, INC. 235004 OR 235451

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention