BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1304-CP2S-7-25-LC-BD

    MDR report key: 2820247 · Received October 31, 2012

    Report

    Report Number
    2030404-2012-00279
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    July 23, 2012
    Report Date
    October 4, 2012
    Manufacturer
    ST. JUDE MEDICAL, INC. (AF-IRVINE)
    Product Code
    OAD
    PMA / PMN Number
    P110016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ONE SAFIRE BLU BI-DIRECTIONAL 7F CATHETER WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION REVEALED THE SHAFT HAD WAVY APPEARANCE. IT WAS ALSO NOTED THAT THE CATHETER SHAFT WAS DAMAGED CLOSED TO STRAIN RELIEF AND INNER COMPONENTS WERE INTACT; HOWEVER, THE OUTER COVER SPRING BODY WAS VISIBLE. THE DAMAGE ON THE SHAFT DID NOT AFFECT THE CATHETER FUNCTIONALITY. THE CATHETER CREATED AND HELD A CURVE IN EACH DIRECTION; HOWEVER, THE CURVES DID NOT MATCH THE REQUIRED TEMPLATE. IT WAS ALSO NOTED THAT THE WAVINESS OF THE SHAFT INCREASED DURING DEFLECTION. THE CATHETER FAILED TORQUE FORCE TESTING. THE WAVY SHAFT IS UNRELATED TO THE EXPOSED INNER COMPONENTS NOTED. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THIS LOT MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. A QUALITY IMPROVEMENT PROJECT HAS BEEN INITIATED TO ADDRESS THE WAVY SHAFT ISSUES. THE ROOT CAUSE CLASSIFICATION OF THE EXPOSED INNER COMPONENTS IS CONSISTENT WITH OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS.

    Description of Event or Problem · 1

    THIS COMPLAINT IS REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(4) 2012. IT WAS REPORTED DURING AN ABLATION PROCEDURE, THE PHYSICIAN HAD DIFFICULTY STEERING WITH A SAFIRE BLU DUO ABLATION CATHETER AND EXCHANGED IT FOR ANOTHER OF THE SAME DEVICE. HE HAD DIFFICULTY STEERING THAT DEVICE ALSO AND EXCHANGED IT FOR ANOTHER SAFIRE BLU CATHETER AND COMPLETED THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE. ANALYSIS RESULTS REVEALED INNER COMPONENTS OF THE DEVICE WERE EXPOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1304-CP2S-7-25-LC-BD CARDIAC ABLATION PERCUTANEOUS CATHETER OAD ST. JUDE MEDICAL, INC. (AF-IRVINE) A088109 3620799

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR SAFIRE BLU DUO ABLATION CATHETER (MODEL A088109,| SAFIRE BLU ABLATION CATHETER (MODEL AND LOT UNK)| LOT UNKNOWN),