BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER

    MDR report key: 2871056 · Received December 12, 2012

    Report

    Report Number
    9673241-2012-00359
    Event Type
    Malfunction
    Date Received
    December 12, 2012
    Date of Event
    November 21, 2012
    Report Date
    November 21, 2012
    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
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT DURING AN ISCHEMIC VENTRICULAR TACHYCARDIA PROCEDURE THE THERMOCOOL SF NAV CATHETER WAS DISPLAYING HIGH IMPEDANCE ON THE STOCKERT GENERATOR. AFTER FAILED ABLATION ATTEMPTS, THE CATHETER WAS REMOVED FROM THE PATIENT. A LARGE AMOUNT OF CHAR FORMATION ON THE CATHETER TIP WAS NOTED. UPON RECEIPT, THE CATHETER WAS VISUALLY INSPECTED AND IT WAS FOUND IN NORMAL CONDITIONS. THEN PER THE EVENT, THE CATHETER WAS TESTED AND IT PASSED ELECTRICAL, TEMPERATURE AND GENERATOR TESTS. AN IRRIGATION TEST WAS ALSO PERFORMED AND IT FAILED, THE IRRIGATION HOLES WERE FOUND OCCLUDED. FURTHER INVESTIGATION REVEALED THAT THE IRRIGATION TUBING WAS NOT OCCLUDED, HOWEVER, CRYSTAL MATERIAL WAS OBSERVED AT THE TIP HOLES. THE CRYSTALLINE MATERIAL WAS INVESTIGATED AND HIGH CONCENTRATION OF SODIUM AND CHLORINE WERE FOUND WHICH ARE TYPICAL ELEMENTS OF THE SALINE SOLUTIONS. THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. THE INVESTIGATION RESULTS SUGGESTED THAT THE CATHETER WAS NOT A DIRECTLY CONTRIBUTOR TO THE CHAR SINCE THE TESTING PERFORMED DEMONSTRATED THE PROPER FUNCTIONALITY OF THE CATHETER. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ISCHEMIC VENTRICULAR TACHYCARDIA PROCEDURE THE THERMOCOOL SF NAV CATHETER WAS DISPLAYING HIGH IMPEDANCE ON THE STOCKERT GENERATOR (APPROXIMATELY AROUND 130 OHMS AND WITHIN 3 SECONDS THE IMPEDANCE ROSE TO THE CUT OFF LIMIT AND SHUT DOWN THE RF DELIVERY AT 250 OHMS). AFTER FAILED ABLATION ATTEMPTS, THE CATHETER WAS REMOVED FROM THE PATIENT. A LARGE AMOUNT OF CHAR FORMATION ON THE CATHETER TIP WAS NOTED. SOME TROUBLE SHOOTING WAS PERFORMED. THE ISSUE WAS FINALLY RESOLVED BY REPLACING THE CATHETER. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1318-04-S 15562083L

    Patients

    Seq Age Sex Outcome Treatment
    1