BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FAST-CATH HEMO INT SWARTZ SRO, 8F, 60CM

    MDR report key: 1002056 · Received February 18, 2008

    Report

    Report Number
    2182269-2008-00012
    Event Type
    Malfunction
    Date Received
    February 18, 2008
    Date of Event
    January 31, 2006
    Report Date
    February 1, 2008
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ONE 8F FAST-CATH HEMOSTASIS INTRODUCER AND DILATOR WERE RECEIVED FOR EVAL. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS LOT MET MFG REQUIREMENTS PRIOR TO SHIPMENT. FUNCTIONAL TESTING REVEALED A LEAK AT THE VALVE. ADDITIONAL TESTING REVEALED THE HEMOSTASIS SEAL WAS TORN AT BOTH ENDS OF THE MFG SLIT WHICH CAUSED THE LEAK AT THE VALVE. HOWEVER, IT IS UNCERTAIN WHAT CAUSED THE SEAL TO TEAR.

    Description of Event or Problem · 1

    IT WAS REPORTED THE INTRODUCER SHEATH LEAKED AT THE VALVE. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FAST-CATH HEMO INT SWARTZ SRO, 8F, 60CM SWARTZ SR 8F DYB ST. JUDE MEDICAL NA 1154590

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK