BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER

    MDR report key: 3407057 · Received October 11, 2013

    Report

    Report Number
    9673241-2013-00344
    Event Type
    Injury
    Date Received
    October 11, 2013
    Date of Event
    September 17, 2013
    Report Date
    September 17, 2013
    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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT ANALYSIS IS CURRENTLY BEING CONDUCTED. THE PRODUCT ANALYSIS CONCLUSION WILL BE SUBMITTED IN SUPPLEMENTAL REPORT UPON COMPLETION. 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). LASSO NAV 2515 CATHETER: US CATALOG # D134301, LOT # 15914277L. TCOOL SF CARTO 3 UN CATHETER: US CATALOG # D131503, LOT # 15879689L. 6FR CS,F,10 POLE,12 PIN,AUTOID CATHETER: US CATALOG # D135304, LOT # 15920201M. SOUNDSTAR ECO SMS 10F CATHETER: US CATALOG # 10438577, SERIAL # (B)(4). COOLFLOW TUBING SET,SINGLE PK: US CATALOG # CFT001, LOT # 104053. PENTARAY NAV, 7FR, F, 4-4-4 CATHETER: US CATALOG # D128201, LOT # 15779929L. CARTO3 EXTERNAL REFPATCH 6PACK (QTY 2): US CATALOG # CREFP6, LOT # LL040313. (B)(4).

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT IT WAS DISCOVERED BEFORE ABLATION STARTED THROUGH ICE THAT THE PATIENT HAD PERICARDIAL EFFUSION AND WAS CONFIRMED THROUGH TTE. 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 ORIGINALLY REPORTED THAT A PERICARDIAL EFFUSION WAS DISCOVERED VIA INTRACARDIAC ECHOCARDIOGRAPHY PRIOR TO THE START OF ABLATION IN AN ATRIAL FIBRILLATION PROCEDURE. THE EFFUSION WAS CONFIRMED THROUGH TRANS-THORACIC ECHOCARDIOGRAM. A PERICARDIOCENTESIS WAS PERFORMED AND 160 CC OF FLUID WAS REMOVED FROM THE PATIENT¿S HEART. ADDITIONAL INFORMATION RECEIVED REVEALED THAT THE PATIENT¿S HEART WAS VERY VERTICAL. A PHYSICIAN WHO SPECIALIZED IN ULTRASOUND WAS CALLED IN TO ASSIST WITH THE TRANSSEPTAL PUNCTURE AND A TRANS- ESOPHAGEAL ECHOCARDIOGRAM WAS USED FOR VISUALIZATION DURING THE PUNCTURE. THERE WAS NO DIFFICULTY MANEUVERING THE CATHETER, HOWEVER THE PATIENT¿S ANATOMY WAS ATYPICAL AND NEEDED SPECIAL ATTENTION. THIS EVENT IS REPORTABLE DUE TO THE SERIOUS INJURY THAT OCCURRED TO THE PATIENT DURING A PROCEDURE USING BIOSENSE WEBSTER PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521616 THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1315-03-S 15879389L

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| L| R