BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1931213 · Received November 11, 2010

    Report

    Report Number
    3005188751-2010-00112
    Event Type
    Malfunction
    Date Received
    November 11, 2010
    Date of Event
    October 7, 2010
    Report Date
    November 8, 2010
    Manufacturer
    ST. JUDE MEDICAL, AF DIVISION
    Product Code
    DRF
    PMA / PMN Number
    K072012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL COMPLAINT DESCRIPTION REC'D ON (B)(4) 2010, OF "3 HRS INTO THE CASE, THE SHAFT OF THE CIRCULAR CATHETER BECAME FLOPPY REDUCING TORQUE AND MANEUVERABILITY MAKING IT DIFFICULT TO ENTER THE RIGHT SIDED VEINS", DID NOT MEET ADVERSE EVENT REPORTING CRITERIA. INVESTIGATION COMPLETED ON (B)(4) 2010, REVEALED A TIP SHAFT BOND SEPARATION, WHICH INDICATES A MALFUNCTION OCCURRED THAT COULD HAVE LED TO AN ADVERSE EVENT. 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. THE DEVICE WAS CONSISTENT WITH HAVING BEEN SEPARATED BY FORCE DURING USE; THE CAUSE FOR THE TIP SHAFT SEPARATION REMAINS UNK. DATE REPORT SUBMITTED TO FDA BY MFR: 11/11/2010. DATE THE INITIAL RPTR PROVIDED THE INFO TO THE MFR: (B)(4) 2010. DATE INVESTIGATION COMPLETED: 11/08/2010.

    Description of Event or Problem · 1

    INVESTIGATION OF A RETURNED DEVICE REVEALED A SHAFT 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 DIVISION D402865 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR