BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER

    MDR report key: 3396794 · Received October 9, 2013

    Report

    Report Number
    2029046-2013-00128
    Event Type
    Injury
    Date Received
    October 9, 2013
    Date of Event
    September 13, 2013
    Report Date
    September 13, 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
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ABLATION CATHETER IS BEING RETURNED FOR ANALYSIS. ANALYSIS CONCLUSIONS WILL BE SUBMITTED TO THE FDA IN A SUPPLEMENTAL REPORT UPON COMPLETION. CONCOMITANT PRODUCTS: COOL FLOW PUMP; US CATALOG # FG540000; SERIAL # (B)(4). STOCKERT 70 SYSTEM; US CATALOG # S7001; SERIAL #(B)(4). COOL FLOW PUMP; US CATALOG # CFP002; SERIAL #(B)(4). (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTION: MANUFACTURING # WAS UPDATED FROM ¿D-1314-05-S¿ TO ¿D-1317-05-S¿ AND LOT NO. FROM ¿UNKNOWN_D-1314-05-S¿ TO ¿15884847L¿ BASED ON THE RESPONSE RECEIVED FROM JEFFREY BAERENWALD REGARDING THE WRONG DEVICE RETURNED STATING THAT A NAV CATHETER THAT WAS USED IN THIS INCIDENT. (B)(4) IT WAS REPORTED THAT DURING AN AFIB CASE, A PERFORATION OF THE LEFT ATRIAL APPENDAGE (LAA) WAS NOTICED AND 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, A COOL FLOW PUMP TEST WAS PERFORMED AS WELL AND THE CATHETER PASSED SPECIFICATIONS. THE CATHETER WAS ALSO EVALUATED FOR EEPROM, CARTO 3, 4 KHZ 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 CATHETER PASSED ALL SPECIFICATIONS. THE ROOT CAUSE OF THE PERICARDIAL EFFUSION REMAINS UNKNOWN. THE IFU STATES THAT CAREFUL CATHETER MANIPULATION MUST BE PERFORMED IN ORDER TO AVOID CARDIAC DAMAGE, PERFORATION OR TAMPONADE. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ATRIAL FIBRILLATION CASE, A PERFORATION OF THE LEFT ATRIAL APPENDAGE (LAA) WAS NOTICED AND CONFIRMED BY INTRACARDIAC ECHOCARDIOGRAPHY. THE CALLER REPORTED THAT A PERICARDIAL EFFUSION HAD BEEN NOTICED BEFORE ABLATING AND THAT THEY PROCEEDED WITH THE CASE BECAUSE THE PATIENT'S VITAL SIGNS WERE STABLE. CALLER ALSO REPORTED THAT NO STEAM POP WAS NOTICED DURING ABLATION AND THAT NO EXCESSIVE USE OF FORCE WAS USED DURING ABLATION. A PERICARDIOCENTESIS WAS PERFORMED AND 150-200 ML OF FLUID WAS REMOVED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. FOLLOW-UP INFORMATION REVEALED THAT THE EVENT OCCURRED DURING THE MAPPING PHASE. THE PHYSICIAN BELIEVES THAT THE EVENT MAY HAVE BEEN ATTRIBUTED TO BOTH CATHETER MANIPULATION AND THE PATIENT¿S LARGE LAA .THE PATIENT WAS HOSPITALIZED FOR TWO DAYS BUT HAS FULLY RECOVERED SINCE THEN. A REPROCESSED LASSO CATHETER AND A NEW THERMOCOOL CATHETER WERE BOTH USED IN THE PROCEDURE. THIS EVENT IS REPORTABLE DUE TO THE SERIOUS INJURY THAT OCCURRED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    512582 THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC (IRWINDALE) D-1317-05-S UNKNOWN_D-1314-05-S

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| L| R