BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER

    MDR report key: 3419048 · Received October 18, 2013

    Report

    Report Number
    9673241-2013-00352
    Event Type
    Injury
    Date Received
    October 18, 2013
    Date of Event
    October 7, 2013
    Report Date
    October 7, 2013
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    PMA / PMN Number
    P030031/S025
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONCOMITANT PRODUCTS: CARTO 3 MODEL# M-4800-01, SERIAL # (B)(4). COOLFLOW PUMP MODEL # M-5491-02 , SERIAL # (B)(4). EZ STEER THERMOCOOL SF NAV MODEL # D-1317-05-S, LOT # UNKNOWN. LASSO NAV VARIABLE ECO MODEL # D-1343-01-S, LOT # 15797604L. STOCKERT MODEL # M-5463-01, SERIAL # (B)(4). (B)(4).

    Additional Manufacturer Narrative · 1

    MANUFACTURER REF # (B)(4). IT WAS REPORTED THAT DURING AN ATRIAL FIBRILLATION (AFIB) PROCEDURE, THE PHYSICIAN HAD DIFFICULTY WITH SECOND TRANSEPTAL UNTIL LEFT ATRIUM (LA) WAS ACCESSED AND PERFORMED APPROXIMATELY 5 RF ABLATIONS ON POSTERIOR WALL OF LEFT SUPERIOR PULMONARY VEIN (LSPV). A PERICARDIAL EFFUSION WAS NOTICED AS THE PATIENT'S BLOOD PRESSURE DROPPED TO 35 SYSTOLIC. THE PERICARDIAL EFFUSION WAS CONFIRMED BY AN ECHOCARDIOGRAM. A PERICARDIOCENTESIS WAS PERFORMED AND IT WAS UNKNOWN HOW MUCH FLUID WAS REMOVED. THE PATIENT WAS REPORTED TO BE IN THE ICU AND IN STABLE CONDITION. THE RETURNED DEVICE WAS VISUALLY INSPECTED UPON RECEIPT AND THE TIP DOME WAS FOUND DAMAGED. THIS CONDITION WAS NOT ORIGINALLY REPORTED BY THE CUSTOMER. ALL THE CATHETERS ARE INSPECTED FOR DEFECTS BEFORE PACKAGING. ON LINE INSPECTIONS ARE IN PLACE TO PREVENT THIS TYPE OF DAMAGE/DEFECT FROM LEAVING THE FACILITY. IT REMAINS UNKNOWN HOW THE TIP DOME WAS DAMAGED. 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 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 PERICARDIAL EFFUSION REMAINS UNKNOWN. THE IFU STATES THAT CAREFUL CATHETER MANIPULATION MUST BE PERFORMED IN ORDER TO AVOID CARDIAC DAMAGE, PERFORATION OR TAMPONADE.

    Additional Manufacturer Narrative · 1

    ON OCTOBER 15, 2013, UPON RECEIVING THE PRODUCT IN BIOSENSE WEBSTER LAB, IT WAS NOTICED THAT TIP DOME DAMAGE AND SHARP AND ROUGH AT DISTAL EDGE. INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT ON DEVICE EVALUATION WILL BE SUBMITTED ONCE IT IS COMPLETED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ATRIAL FIBRILLATION (AFIB) PROCEDURE, THE PHYSICIAN HAD DIFFICULTY WITH SECOND TRANSEPTAL UNTIL LEFT ATRIUM (LA) WAS ACCESSED AND PERFORMED APPROXIMATELY 5 RF ABLATIONS ON POSTERIOR WALL OF LEFT SUPERIOR PULMONARY VEIN (LSPV). A PERICARDIAL EFFUSION WAS NOTICED AS THE PATIENT'S BLOOD PRESSURE DROPPED TO 35 SYSTOLIC. THE PERICARDIAL EFFUSION WAS CONFIRMED BY AN ECHOCARDIOGRAM. A PERICARDIOCENTESIS WAS PERFORMED AND IT WAS UNKNOWN HOW MUCH FLUID WAS REMOVED. THE PATIENT WAS REPORTED TO BE IN THE ICU AND IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534814 THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1317-05-S 15918088L

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R