BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FAST-CATH RAMP HEMOSTASIS INTRODUCER, 8F, 60CM

    MDR report key: 1002064 · Received February 18, 2008

    Report

    Report Number
    2182269-2008-00025
    Event Type
    Malfunction
    Date Received
    February 18, 2008
    Date of Event
    March 16, 2006
    Report Date
    February 1, 2008
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ONE 8F FAST-CATH INTRODUCER, DILATOR AND A GUIDEWIRE WERE RECEIVED FOR EVAL. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS LOT MET MFG REQUIREMENTS PRIOR TO SHIPMENT. THE RETURNED INTRODUCER AND GUIDEWIRE WERE DETERMINED TO BE GOOD PRODUCT. THE DILATOR WAS RECEIVED IN TWO PIECES WHICH HAD SEPARATED NEAR THE DISTAL END. MICROSCOPIC EXAMINATION REVEALED SLIGHT ELONGATION ON THE BOTH HALVES OF SEPARATED DILATOR.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DISTAL TIP OF THE DILATOR DETACHED ON THE STERILE TABLE DURING INSERTION INTO THE SHEATH. ANOTHER DEVICE FROM THE SAME REORDER NUMBER WAS THEN USED. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FAST-CATH RAMP HEMOSTASIS INTRODUCER, 8F, 60CM FAST CATH RAMP 8F, 60CM DYB ST. JUDE MEDICAL NA 1186606

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK