BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER

    MDR report key: 4090781 · Received September 15, 2014

    Report

    Report Number
    2029046-2014-00300
    Event Type
    Malfunction
    Date Received
    September 15, 2014
    Date of Event
    August 8, 2014
    Report Date
    August 11, 2014
    Manufacturer
    BIOSENSE WEBSTER, INC (IRWINDALE)
    Product Code
    LPB
    PMA / PMN Number
    P030031/S025
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER REF # (B)(4) IT WAS REPORTED THAT DURING A CARDIAC EP STUDY WITH ABLATION PROCEDURE, MULTIPLE TIMES DURING THE ABLATION PHASE OF THE PROCEDURE, THE COOLFLOW PUMP WOULD STOP IRRIGATION AND REBOOT. "88" IN DISPLAY. DUE TO THE FAILURES OF THE PUMP, THE NAV SF MAPPING/ABLATION CATHETER BECAME BLOCKED WITH BLOOD AND WOULD NOT IRRIGATE. UPON RECEIPT, THE CATHETER WAS VISUALLY INSPECTED AND IT WAS FOUND IN NORMAL CONDITIONS. THEN PER THE REPORTED EVENT, AN ELECTRICAL TEST WAS PERFORMED AND CATHETER PASSED. IN ADDITION, AN IRRIGATION TEST WAS PERFORMED AND CATHETER FAILED. THE CATHETER WAS THEN DISSECTED AND IT WAS NOTICED THAT THE IRRIGATION TUBING WAS KINKED INSIDE THE HANDLE 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. ALL THE CATHETERS ARE 100% INSPECTED FOR IRRIGATION BEFORE PACKAGING. THE CUSTOMER COMPLAINT HAS BEEN VERIFIED.

    Additional Manufacturer Narrative · 1

    THE CONCOMITANT PRODUCTS: THERMOCOOL SF NON-NAV, D-F, TC MODEL# D-1314-05-S, LOT # UNKNOWN. COOL FLOW PUMP,EUROPE SHIP KIT MODEL # M-5491-01, SERIAL # (B)(4). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CARDIAC EP STUDY WITH ABLATION PROCEDURE, MULTIPLE TIMES DURING THE ABLATION PHASE OF THE PROCEDURE, THE COOLFLOW PUMP WOULD STOP IRRIGATION AND REBOOT, "88" IN DISPLAY. DUE TO THE FAILURES OF THE PUMP, THE NAV SF MAPPING/ABLATION CATHETER BECAME BLOCKED WITH BLOOD AND WOULD NOT IRRIGATE. THE DELAY WAS 60 MINUTES AND THE TOTAL OF PROCEDURE WAS APPROXIMATELY 4 HOURS. UPON FOLLOWING UP WITH THE CUSTOMER, BWI RECEIVED ADDITIONAL INFORMATION ON (B)(4) 2014 WHICH IS NOW INDICATIVE OF A REPORTABLE EVENT. IT WAS STATED THAT THE PHYSICIAN CONSIDERED THAT THE DELAY CAUSED A POTENTIAL RISK TO THIS PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568576 THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC (IRWINDALE) D-1317-05-S UNKNOWN_D-1317-05-S

    Patients

    Seq Age Sex Outcome Treatment
    1