BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER

    MDR report key: 3010598 · Received March 19, 2013

    Report

    Report Number
    2029046-2013-00034
    Event Type
    Injury
    Date Received
    March 19, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 6, 2013
    Manufacturer
    BIOSENSE WEBSTER, INC (IRWINDALE)
    Product Code
    LPB
    PMA / PMN Number
    P030031/S025
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONCOMITANT PRODUCTS: CARTO 3: MODEL# M-4800-01, SERIAL # (B)(4). STOCKERT: MODEL# M-5463-01, SERIAL # (B)(4). COOLFLOW PUMP: MODEL# M-5491-02, SERIAL # (B)(4). (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT DURING AN AFIB PROCEDURE, A PERFORATION OF THE LEFT ATRIUM (POSSIBLY THE LEFT ATRIAL APPENDAGE) WAS NOTED AS THE PATIENT'S BLOOD PRESSURE DROPPED. THE PERFORATION WAS CONFIRMED BY ICE. THE RETURNED DEVICE WAS VISUALLY INSPECTED UPON RECEIPT AND IT WAS FOUND IN NORMAL CONDITIONS. PER THE EVENT, THE CATHETER WAS TESTED FOR ELECTRICAL PERFORMANCE, TEMPERATURE RESPONSE AND STOCKERT COMPATIBILITY AND IT WAS FOUND WITHIN SPECIFICATIONS. FURTHERMORE, AN IRRIGATION TEST WAS PERFORMED AND THE CATHETER PASSED, NO OCCLUSION WAS OBSERVED. A COOL FLOW PUMP TEST WAS PERFORMED AS WELL AND THE CATHETER PASSED SPECIFICATIONS. THE CATHETER WAS ALSO EVALUATED FOR EEPROM, CARTO 3, AND CALIBRATION FUNCTIONALITY. THE CATHETER WAS RECOGNIZED BY CARTO 3 SYSTEM, NO ERROR MESSAGES WERE DISPLAYED AND THE CATHETER WAS PROPERLY VISUALIZED. EEPROM DATA DEMONSTRATES THE CATHETER WAS PROPERLY CALIBRATED DURING MANUFACTURING. FINALLY, A DEFLECTION TEST WAS PERFORMED AND THE CATHETER PASSED. 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 CATHETER PASSED ALL SPECIFICATIONS. THE ROOT CAUSE OF THE PERFORATION REMAINS UNKNOWN. THE IFU STATES THAT CAREFUL CATHETER MANIPULATION MUST BE PERFORMED IN ORDER TO AVOID CARDIAC DAMAGE, PERFORATION OR TAMPONADE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN AFIB PROCEDURE, A PERFORATION OF THE LEFT ATRIUM (POSSIBLY THE LEFT ATRIAL APPENDAGE) WAS NOTED AS THE PATIENT'S BLOOD PRESSURE DROPPED. THE PERFORATION WAS CONFIRMED BY ICE. A PERICARDIOCENTESIS WAS PERFORMED AND THE PATIENT IS IN STABLE CONDITION. THIS IS THE PHYSICIAN'S FIRST PATIENT AFIB ABLATION IN 8 MONTHS AND HIS FIRST AFIB ABLATION OUT OF FELLOWSHIP. THE PHYSICIAN'S OPINION REGARDING THE CAUSALITY OF THIS EVENT WAS MANIPULATION THE ABLATION CATHETER AROUND THE LEFT ATRIUM. THE PHYSICIAN WAS HAVING TROUBLE MOVING THE CATHETER BECAUSE HIS TRANSEPTAL SHEATHS WERE NOT WORKING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113457 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 Hospitalization| L| R