BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FAST-CATH HEMOSTASIS INTRODUCER 6F, 12CM SHEATH

    MDR report key: 1950267 · Received December 14, 2010

    Report

    Report Number
    3005188751-2010-00131
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    November 17, 2010
    Report Date
    November 17, 2010
    Manufacturer
    ST. JUDE MEDICAL, AF DIVISION
    Product Code
    DYB
    PMA / PMN Number
    K894343
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE AWAITING DEVICE RETURN. WHEN OUR INVESTIGATION HAS BEEN COMPLETED, A FOLLOW UP REPORT WILL BE SUBMITTED. DATE REPORT SUBMITTED TO FDA BY MFR: (B)(4) 2010. DATE THE INITIAL REPORTER PROVIDED THE INFO TO THE MFR: (B)(4) 2010.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN REMOVING THE SHEATH FROM THE FEMORAL VEIN FOLLOWING A SVT ABLATION PROCEDURE, THE HEAD OF THE 6F SHEATH SEPARATED FROM THE BODY OF THE SHEATH. THE PT WAS IN STABLE CONDITION AND WAS TAKEN TO THE OPERATING ROOM FOR REMOVAL OF SHEATH BODY FROM THE FEMORAL VEIN. THE PHYSICIAN STATED, THE STAFF MEMBER WHO REMOVED THE SHEATH, SIMULTANEOUSLY PULLED AND APPLIED PRESSURE CAUSING SEPARATION OF THE SHEATH HEAD FROM THE BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FAST-CATH HEMOSTASIS INTRODUCER 6F, 12CM SHEATH FAST-CATH 6F, 12CM DYB ST. JUDE MEDICAL, AF DIVISION 406701 3223453

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR