BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL® SF UNI-DIRECTIONAL CATHETER

    MDR report key: 3242813 · Received July 23, 2013

    Report

    Report Number
    9673241-2013-00248
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    July 1, 2013
    Report Date
    July 3, 2013
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    PMA / PMN Number
    P030031/S034
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4) IT WAS REPORTED THAT AFTER AN ATRIAL FLUTTER (AFL) PROCEDURE , THE CUSTOMER WAS NOTICED CHARRING ON THE PROXIMAL PART OF THE TIP. THE SIZE OF CHAR WAS 1 MM BUT WAS NOT AROUND THE TIP CATHETER. THE CUSTOMER STARTED ABLATION WITH 20WATTS/300SEC AND AT THE END OF THE PROCEDURE SOME ABLATIONS WITH 30WATTS / 300SEC. THE RETURNED DEVICE WAS VISUALLY INSPECTED UPON RECEIPT AND CHAR WAS OBSERVED ON THE PROXIMAL SIDE OF TIP DOME. PER THE EVENT, THE CATHETER WAS TESTED FOR ELECTRICAL PERFORMANCE, TEMPERATURE RESPONSE AND STOCKERT COMPATIBILITY AND IT WAS FOUND WITHIN SPECIFICATIONS. FURTHERMORE, A COOL FLOW PUMP TEST WAS ALSO PERFORMED AND THE CATHETER PASSED SPECIFICATIONS. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. THE CUSTOMER COMPLAINT HAS BEEN VERIFIED. HOWEVER, CATHETER MET MANUFACTURING SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER AN ATRIAL FLUTTER (AFL) PROCEDURE , THE CUSTOMER NOTICED CHARRING ON THE PROXIMAL PART OF THE TIP. THE SIZE OF CHAR WAS 1 MM BUT WAS NOT AROUND THE TIP CATHETER. THE CUSTOMER STARTED ABLATION WITH 20WATTS/300SEC AND AT THE END OF THE PROCEDURE SOME ABLATIONS WITH 30WATTS/300SEC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343678 THERMOCOOL® SF UNI-DIRECTIONAL CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1316-03-S 15786712L

    Patients

    Seq Age Sex Outcome Treatment
    1