BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REFLEXION SPIRAL X, 7F, VAR, RADIUS CIR. MAP. CATH

    MDR report key: 1932078 · Received November 30, 2010

    Report

    Report Number
    3005188751-2010-00120
    Event Type
    Malfunction
    Date Received
    November 30, 2010
    Date of Event
    October 28, 2010
    Report Date
    November 3, 2010
    Manufacturer
    ST. JUDE MEDICAL, AF DIV
    Product Code
    DRF
    PMA / PMN Number
    K072012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION OF THE RETURNED CATHETER REVEALED THE TIP SHAFT BOND HAD SEPARATED. EVIDENCE OF THE TIP SHAFT HAVING BEEN ADEQUATELY SECURED WITH UV ADHESIVE WAS CONFIRMED BY THE PRESENCE OF A UNIFORMED BAND OF ADHESIVE AROUND THE ENTIRE TIP SHAFT. VISUAL APPEARANCE OF THE SEPARATION WAS CONSISTENT WITH HAVING ENCOUNTERED RESISTANCE AT THE DISTAL TIP SHAFT AND FORCE HAVING BEEN APPLIED TO THE PROXIMAL HALF OF THE SHAFT CAUSING THE SEPARATION. THE CATHETER WAS STILL ABLE TO DEFLECT CORRECTLY IN BOTH DIRECTIONS AND THE LOOP DOES CINCH WHEN ACTUATING THE LEVER. NO DEFLATION ANOMALIES WERE NOTED. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS LOT MET MFG REQUIREMENTS PRIOR TO SHIPMENT. (B)(4).

    Description of Event or Problem · 1

    INVESTIGATION OF A CATHETER WHICH WAS RETURNED FOR PROBLEMS WITH DEFLATION, REVEALED A TIP BOND SEPARATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REFLEXION SPIRAL X, 7F, VAR, RADIUS CIR. MAP. CATH REFLEXION SPIRAL X, 7F DRF ST. JUDE MEDICAL, AF DIV D402865 3221055

    Patients

    Seq Age Sex Outcome Treatment
    1