BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVISTAR¿ DS ELECTROPHYSIOLOGY CATHETER

    MDR report key: 3240477 · Received July 22, 2013

    Report

    Report Number
    9673241-2013-00241
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    June 25, 2013
    Report Date
    June 26, 2013
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    OAD
    PMA / PMN Number
    P010068
    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 DURING AN ATRIAL FLUTTER (AFL) PROCEDURE WITH CARTO3, THE PHYSICIAN HEARD A POP AT THE END OF ABLATION. THE STOCKERT SETTINGS WERE TEMPERATURE LIMIT 65 C AND 50 WATT AND IT WAS TEMPERATURE CONTROL MODE. THE PHYSICIAN FOUND CHARRING AT THE TIP OF THE CATHETER. THERE WAS NO PATIENT CONSEQUENCE AND THE SIZE OF CHAR IS UNKNOWN. UPON RECEIPT, THE DEVICE WAS VISUALLY INSPECTED AND IT WAS FOUND IN NORMAL CONDITIONS. THEN PER THE REPORTED EVENT, THE CATHETER WAS TESTED AND IT PASSED ELECTRICAL, TEMPERATURE AND GENERATOR TESTS. THE DEVICE HISTORY RECORD 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 CATHETER PASSED ALL SPECIFICATIONS. THE ROOT CAUSE OF THE POP AND CHAR REMAINS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ATRIAL FLUTTER (AFL) PROCEDURE WITH CARTO3, THE PHYSICIAN HEARD A POP AT THE END OF ABLATION. THE STOCKERT SETTINGS WERE TEMPERATURE LIMIT 65 C AND 50 WATT AND IT WAS TEMPERATURE CONTROL MODE. THE PHYSICIAN FOUND CHARRING AT THE TIP OF THE CATHETER. THERE WAS NO PATIENT CONSEQUENCE AND THE SIZE OF CHAR IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341307 NAVISTAR¿ DS ELECTROPHYSIOLOGY CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD BIOSENSE WEBSTER, INC. (JUAREZ) D-1201-17-S 15724307M

    Patients

    Seq Age Sex Outcome Treatment
    1