BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXIMUM HEMOSTASIS INTRODUCER 6F, 12CM ACT SHEATH

    MDR report key: 833562 · Received March 28, 2007

    Report

    Report Number
    2182269-2007-00078
    Event Type
    Injury
    Date Received
    March 28, 2007
    Date of Event
    March 8, 2007
    Report Date
    March 14, 2007
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    DYB
    PMA / PMN Number
    K870374
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO USED PRODUCT WAS RETURNED FOR EVAL. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS LOT MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. A SKETCH WAS INCLUDED OF THE USED PRODUCT BY THE REP. THE SEPARATION OF THE SHEATH BODY FROM THE HUB OCCURRED AT THE SHRINK WRAP COLLAR. THE SHEATH BODY HAD SEPARATED CLEANLY. BASED ON THE INFO REC'D, THE CAUSE FOR THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. ONE UNUSED 6F MAXIMUM SHEATH INTRODUCER FROM LOT 1232971 WAS REC'D IN A CARDBOARD ENVELOPE AND THE ENVELOPE WAS IN GOOD CONDITION. THE INTRODUCER WAS WITHIN AN UNSEALED POUCH. THE DEVICE WAS IN GOOD CONDITION. THE INTRODUCER MET VISUAL INSPECTION CRITERIA FOR PACKAGING UNDER DEPT PROCEDURES 002297 AND 001407. THE PULL TEST OF THE SHEATH WAS WITHIN SPECIFICATION AND NO INDICATION OF SEPARATION OCCURRED. THE HUB WAS CUT DOWN THE CENTER. A VISUAL INSPECTION OF THE HUB/SHEATH INTERFACE FOUND A NEATLY ROUNDED SHEATH HEAD WITH SHEATH MATERIAL WASHING DOWN THE SIDES AND HUB MATERIAL UNDERNEATH THE COLLAR. ALL OF WHICH ARE CHARACTERISTIC OF A STRONG DESIGN. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS LOT MET SPECIFICATION PRIOR TO SHIPMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXIMUM HEMOSTASIS INTRODUCER 6F, 12CM ACT SHEATH MAXIMUM 6F, 12CM ACT DYB ST. JUDE MEDICAL NA 1232971

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Life Threatening| R