BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FAST-CATH HEMO. INT., 8.5F, SWARTZ SL1, TRANS.

    MDR report key: 1800074 · Received August 11, 2010

    Report

    Report Number
    3005188751-2010-00074
    Event Type
    Malfunction
    Date Received
    August 11, 2010
    Report Date
    July 15, 2010
    Manufacturer
    ST. JUDE MEDICAL, AF DIVISION
    Product Code
    DYB
    PMA / PMN Number
    K061015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LEAK TESTING OF THE RETURNED INTRODUCER CONFIRMED A LEAK AT THE VALVE CAUSED BY A TEAR AT BOTH ENDS OF THE MFG SLIT. THE TEAR WAS CONSISTENT WITH INSERTION OF AN OBJECT TOO LARGE FOR THE SEAL. REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THIS LOT MET MFG REQUIREMENTS PRIOR TO SHIPMENT. DATE REPORT SUBMITTED TO FDA BY MFR: 08/11/10. DATE THE INITIAL REPORTER PROVIDED INFO TO THE MFR: (B)(6) 2010.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS A LEAK AT THE HEMOSTASIS VALVE. THERE WERE NO CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FAST-CATH HEMO. INT., 8.5F, SWARTZ SL1, TRANS. FAST-CATH TRANSSEPTAL DYB ST. JUDE MEDICAL, AF DIVISION 406849 2788285

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK