BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER

    MDR report key: 3718681 · Received April 1, 2014

    Report

    Report Number
    9673241-2014-00124
    Event Type
    Injury
    Date Received
    April 1, 2014
    Date of Event
    March 17, 2014
    Report Date
    March 17, 2014
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    PMA / PMN Number
    P030031/S034
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE LOT # 16044772L WAS PROVIDED, THE DEVICE HISTORY RECORDS 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. CONCOMITANT BWI PRODUCTS: CARTO 3 SYSTEM; US CATALOG # FG540000; SERIAL # (B)(4). STOCKERT 70 RF GENERATOR; US CATALOG # S7001; SERIAL # (B)(4). COOLFLOW IRRIGATION PUMP; US CATALOG # CFP002; SERIAL # (B)(4). THERMOCOOL SF NAV UNI-DIRECTIONAL CATHETER; US CATALOG # D131503; LOT # 16044772L. WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY AND AUTO ID; US CATALOG # BD710DF282CT; LOT # 16069870M. LASSO NAV ECO CATHETER; US CATALOG # D134901; LOT # 16014979L. THERE WERE THREE COMPETITOR'S PRODUCTS USED AND INVOLVED IN THIS EVENT OF ST. JUDE MEDICAL. A NOTIFICATION OF THE REPORTED EVENT WAS SENT. MANUFACTURER'S REFERENCE # (B)(4), ARE RELATED TO THE SAME EVENT. THE DEVICE INVESTIGATION IS STILL IN PROGRESS. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4) DURING AN ATRIAL FIBRILLATION PROCEDURE, IT WAS REPORTED THAT IT WAS LOST LEFT SIDED ACCESS WHEN MAPPING WITH THE F CURVE SF CATHETER. THE PHYSICIAN SWITCHED TO THE D CURVE SF WITH DIFFICULTY MAPPING. IT WAS NOTICED A DECREASE IN THE PATIENT¿S BLOOD PRESSURE AND ULTRASOUND CONFIRMED A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED EXTRACTING 300 CUBIC CENTIMETERS (CC¿S) OF RED COLORED FLUID. THE PATIENT STABILIZED AND THE PROGNOSIS WAS GOOD. THE RETURNED DEVICE WAS VISUALLY INSPECTED AND FOUND IN GOOD PHYSICAL CONDITION. PER THE EVENT, THE CATHETER WAS TESTED FOR ELECTRICAL PERFORMANCE, TEMPERATURE RESPONSE AND STOCKERT COMPATIBILITY AND WAS FOUND WITHIN SPECIFICATIONS. FURTHERMORE, AN IRRIGATION TEST WAS PERFORMED AND THE CATHETER PASSED, NO OCCLUSION WAS OBSERVED. 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.

    Description of Event or Problem · 1

    DURING AN ATRIAL FIBRILLATION PROCEDURE, IT WAS REPORTED THAT IT WAS LOST LEFT SIDED ACCESS WHEN MAPPING WITH THE F CURVE SF CATHETER. THE PHYSICIAN SWITCHED TO THE D CURVE SF WITH DIFFICULTY MAPPING. IT WAS NOTICED A DECREASE IN THE PATIENT¿S BLOOD PRESSURE AND ULTRASOUND CONFIRMED A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED EXTRACTING 300 CUBIC CENTIMETERS (CC¿S) OF RED COLORED FLUID. THE PATIENT STABILIZED AND THE PROGNOSIS WAS GOOD. ON (B)(4), RECEIVED ADDITIONAL INFORMATION REQUESTED FROM BWI REPRESENTATIVE STATING THAT WHEN USED NAVTC SF (F CURVE) TO PUSH THROUGH SINGLE PUNCTURE SITE AND ADVANCE CATHETER INTO LEFT ATRIUM (LA), A SECOND SHEATH (COMPETITOR¿S) WAS THEN ADVANCED INTO LA OVER THE CATHETER. THE PHYSICIAN WAS UNABLE TO NORMALLY MANIPULATE THE CATHETER WHILE ATTEMPTING TO MAP LA; FELT THAT THE CURVE WAS BIG FOR LA SIZE, SO THE CATHETER WAS EXCHANGED FOR NAVTC SF (D CURVE). IT WAS STATED THAT THE MANIPULATION MAY HAVE CAUSED EFFUSION BY ADVANCING NAVTC SF (FCURVE) THROUGH THE LAA DURING INITIAL MAPPING PHASE OF PROCEDURE. THE PATIENT REQUIRED HOSPITALIZATION. THE OUTCOME OF THE PATIENT WAS A FULL RECOVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193752 THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1315-03-S 16044772L

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| L| R