BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER

    MDR report key: 3002084 · Received March 13, 2013

    Report

    Report Number
    9673241-2013-00062
    Event Type
    Injury
    Date Received
    March 13, 2013
    Date of Event
    February 13, 2013
    Report Date
    February 13, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT BLOOD'S PRESSURE DROPPED AND A X-RAY AND ECHO CONFIRMED A PERICARDIAL EFFUSION. 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, 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 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.

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS STILL IN PROCESS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA ONCE THAT THE PRODUCT ANALYSIS INVESTIGATION IS COMPLETED. CONCOMITANT PRODUCTS: CARTO 3 SYSTEM 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PVC (PREMATURE VENTRICULAR CONTRACTION) PROCEDURE, THE PATIENT BLOOD'S PRESSURE DROPPED. X-RAY AND ECHO CONFIRMED A PERICARDIAL EFFUSION. PERICARDIOCENTESIS WAS PERFORMED. THE PHYSICIAN'S OPINION REGARDING THE CAUSALITY OF THE PERICARDIAL EFFUSION WAS HIS FAULT SINCE HE PUSHED TOO HARD AND CAME ON RF. THE PHYSICIAN TOOK FULL RESPONSIBILITY FOR IT. IT WAS ALSO STATED THAT THE EVENT WAS POSSIBLE PROCEDURE RELATED. THE PATIENT OUTCOME OF THE ADVERSE EVENT WAS "FULLY RECOVERED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105863 THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1313-05-S 15692314L

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| L| R