BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTIMUM HEMOSTASIS INTRODUCER, 6F ACT, 12CM SHEATH

    MDR report key: 1051317 · Received May 23, 2008

    Report

    Report Number
    2182269-2008-00144
    Event Type
    Malfunction
    Date Received
    May 23, 2008
    Report Date
    April 28, 2008
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    DYB
    PMA / PMN Number
    K001346
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE 6F, 12CM, ULTIMUM HEMOSTASIS SHEATH WAS RETURNED FOR EVALUATION. THE SHEATH TUBING HAD BEEN SEPARATED FROM THE HEMOSTASIS HUB AT THE TUBING HEAD. THE PROXIMAL END OF THE DETACHED TUBING SEGMENT AND THE DISTAL END OF THE ATTACHED TUBING SEGMENT (WITHIN THE HEMOSTASIS HUB) REVEALED MATERIAL THAT WAS STRETCHED AND TORN, CONSISTENT WITH FORCIBLE SEPARATION. NO ANOMALIES WERE NOTED. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS LOT MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. INTERNAL CORRECTIVE ACTIONS WERE IMPLEMENTED TO ADDRESS THE SOLVENT APPLICATION DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING THE INSERTION OF THE SHEATH, THE PHYSICIAN INSERTED THE CATHETER INTO THE SHEATH. THE HUB DISCONNECTED FROM THE BODY OF THE SHEATH. THE PHYSICIAN IMMEDIATELY HELD PRESSURE PROXIMAL TO THE INSERTION SITE. A SMALL PORTION OF THE SHEATH SHAFT WAS STICKING OUT OF THE SKIN SO THE PHYSICIAN WAS ABLE TO RETRIEVE THE SHEATH. MANUAL PRESSURE WAS HELD. THERE WERE NO REPORTED CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTIMUM HEMOSTASIS INTRODUCER, 6F ACT, 12CM SHEATH ULTIMUM INTRODUCER DYB ST. JUDE MEDICAL NA 2049451

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK