BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FAST-CATH HEMOSTASIS INTRODUCER, 4F, 8.5CM SHEATH

    MDR report key: 1060519 · Received June 11, 2008

    Report

    Report Number
    2182269-2008-00157
    Event Type
    Malfunction
    Date Received
    June 11, 2008
    Date of Event
    May 20, 2008
    Report Date
    May 20, 2008
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    DYB
    PMA / PMN Number
    K870374
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE 4F, 8.5CM, FAST-CATH HEMOSTASIS SHEATH WAS RETURNED FOR EVALUATION. THE SHEATH TUBING HAD BEEN DETACHED WITHIN THE HUB; THE TUBING MATING ENDS WERE RELATIVELY CLEAN WITHOUT OBVIOUS STRETCHING OR TEARING OF MATERIAL. THE DETACHED TUBING SEGMENT HAD CONTINUED AND CRIMP-LIKE MARKS, CONSISTENT WITH MECHANICAL CONTACT. NO OTHER VISUAL ANOMALIES WERE NOTED. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS LOT MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. INTERNAL CORRECTIVE ACTIONS HAVE BEEN IMPLEMENTED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED, THE SHEATH AND DILATOR WERE INSERTED OVER THE WIRE AND INTO THE PATIENT'S VEIN. THE PHYSICIAN NOTICED UNDER FLUOROSCOPY THAT THE TUBE OF THE SHEATH HAD BECOME DISCONNECTED FROM THE HUB AND WAS ADVANCING DOWN THE VEIN AND OVER THE WIRE AS HE PULLED THE DILATOR BACK. HE WAS ABLE TO INSERT A SNARE TO RETRIEVE THE TUBE PORTION OF THE SHEATH. ANOTHER SHEATH WAS USED WITHOUT COMPLICATIONS. THERE WERE NO REPORTED CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FAST-CATH HEMOSTASIS INTRODUCER, 4F, 8.5CM SHEATH FAST CATH INTRODUCER DYB ST. JUDE MEDICAL NA 2051028

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention