BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPREME EP CATHETER 5F, DECAPOLAR, CSL, 120 CM

    MDR report key: 1002062 · Received February 18, 2008

    Report

    Report Number
    2182269-2008-00020
    Event Type
    Malfunction
    Date Received
    February 18, 2008
    Date of Event
    January 5, 2007
    Report Date
    February 1, 2008
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    DRF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ONE 5F SUPREME EP CATHETER WAS RECEIVED FOR EVAL. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS LOT MET MFG REQUIREMENTS PRIOR TO SHIPMENT. VISUAL INSPECTION REVEALED A SEPARATION AT THE TRANSITION BETWEEN THE GRAY AND BLACK SHAFT. MICROSCOPIC EXAMINATION REVEALED NO ELONGATION OF THE MATERIAL AT THE SEPARATION SITE. CORRECTIVE ACTION WAS INITIATED ON 2/28/2007 TO INVESTIGATE CATHETER SHAFT SEPARATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED A CATHETER BOND JOINT SEPARATED. THE CATHETER REMAINED INTACT. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPREME EP CATHETER 5F, DECAPOLAR, CSL, 120 CM SUPREME EP 5F, DECA DRF ST. JUDE MEDICAL NA 1239075

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK