BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVISTAR® THERMOCOOL®

    MDR report key: 3771696 · Received April 24, 2014

    Report

    Report Number
    2029046-2014-00122
    Event Type
    Injury
    Date Received
    April 24, 2014
    Date of Event
    March 27, 2014
    Report Date
    March 28, 2014
    Manufacturer
    BIOSENSE WEBSTER, INC (IRWINDALE)
    Product Code
    OAD
    PMA / PMN Number
    P030031
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION STILL IN PROGRESS. A SUPPLEMENTAL REPORT OR DEVICE EVALUATION WILL BE SUBMITTED. CONCOMITANT PRODUCTS: 1.CARTO 3 SYSTEM: MODEL #: UNKNOWN, SERIAL #: UNKNOWN. 2. STOCKERT : MODEL #: UNKNOWN, SERIAL #: UNKNOWN. 3. COOL FLOW PUMP: MODEL #: UNKNOWN, SERIAL #: UNKNOWN. (B)(4).

    Additional Manufacturer Narrative · 1

    THE ORIGINAL REPORTED LOT NUMBER WAS REPORTED AS UNKNOWN. PER THE BWI FAILURE ANALYSIS LAB, AFTER TESTING THE RETURNED PRODUCT, THE LOT NUMBER WAS IDENTIFIED AS 16045459M. (B)(4) IT WAS REPORTED THAT THE CATHETER FOLDED ON ITSELF IN A KNOT-LIKE FASHION. IT WAS ALSO NOTICED THAT THE CATHETER STAYED IN THE DEFLECTED POSITION AND THAT IT WOULD NOT RELAX BACK TO ITS NATIVE CONFORMATION. IN ADDITION, DURING THE SAME PROCEDURE, A PERFORATION OF THE LEFT ATRIUM WAS NOTICED AS THE PATIENT'S BLOOD PRESSURE DROPPED. THE RETURNED DEVICE WAS VISUALLY INSPECTED UPON RECEIPT AND IT WAS FOUND IN NORMAL CONDITIONS. DUE TO THE PERFORATION, 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. 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. DUE TO THE DEFLECTION AND KNOT ¿ LIKE FASHION ISSUE, A DEFLECTION TEST WAS PERFORMED AND THE CATHETER FAILED. FURTHER INVESTIGATION REVEALED THAT THE PULLER WIRE WAS BROKEN INSIDE THE HANDLE. CATHETER WAS NOT STUCK IN DEFLECTED POSITION SINCE THE PULLER WIRE WAS BROKEN, CATHETER RETURNED BY ITSELF TO ITS ORIGINAL POSITION AND THE CATHETER CAN¿T BE MANEUVERED AT ALL. THEREFORE, IT REMAINS UNKNOWN HOW THE CATHETER GOT STUCK IN DEFLECTED POSITION AND HOW THE KNOT WAS MADE. 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 REPORTED CUSTOMER COMPLAINT CANNOT BE CONFIRMED. THE ROOT CAUSE OF THE PERFORATION 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

    IT WAS REPORTED THAT DURING THE ATRIAL FIBRILLATION (AFIB) PROCEDURE, THE CATHETER FOLDED ON ITSELF IN A KNOT-LIKE FASHION. WHEN THE PHYSICIAN REMOVED THE CATHETER FROM THE PATIENT'S BODY, IT WAS NOTICED THAT THE CATHETER STAYED IN THE DEFLECTED POSITION AND THAT IT WOULD NOT RELAX BACK TO ITS NATIVE CONFORMATION. THE CATHETER WAS REPLACED WITH THE SAME TYPE OF PRODUCT (SAME CATALOG NUMBER). ADDITIONAL CLARIFICATION WAS REQUESTED ON THIS ISSUE. HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. THE DEFLECTION ISSUE REPORTED IS INDICATIVE OF A REPORTABLE ISSUE. IT WILL BE REPORTED UNDER ((B)(4)). IT WAS ALSO REPORTED THAT DURING THE SAME PROCEDURE, A PERFORATION OF THE LEFT ATRIUM WAS NOTICED AS THE PATIENT'S BLOOD PRESSURE DROPPED. THE PERFORATION WAS CONFIRMED BY FLUOROSCOPY AND ULTRASOUND. A PERICARDIOCENTESIS AND SURGERY WERE PERFORMED. HOWEVER, THE VOLUME OF FLUID REMOVED WAS UNKNOWN. THE STATUS OF THE PATIENT WAS UNKNOWN. UPON REQUEST, ADDITIONAL CLARIFICATION WAS PROVIDED ON THE PATIENT EVENT. THE EVENT WAS A CARDIAC PERFORATION AND A TAMPONADE. THE PATIENT EVENT OCCURRED DURING THE MAPPING PHASE. THE PHYSICIAN¿S OPINION REGARDING THE CAUSALITY WAS UNKNOWN. BEFORE THE EVENT WAS NOTICED, THE PHYSICIAN DID NOT EXPERIENCE ANY ISSUE IN MANIPULATING THE SECOND NAVISTAR THERMOCOOL CATHETER. THE PHYSICIAN DID NOT NOTICE ANY ABNORMAL SIGNALS. IT WAS UNKNOWN HOW MANY ABLATIONS THE PATIENT RECEIVED BEFORE THE EVENT. THE RF GENERATOR WAS SET TO THE MANUAL SETTING FOR THE THERMOCOOL. THE POWER, TEMPERATURE AND FLOW SETTING WERE UNKNOWN. THE TYPE OF SHEATH USED WAS UNKNOWN. THE PATIENT RECEIVED ANTICOAGULATION IN THE PROCEDURE. HOWEVER, THE ACT MAINTAINED WAS UNKNOWN. IT WAS UNKNOWN THE PATIENT¿S BASELINE HEALTH STATUS BEFORE THE PROCEDURE. THE PATIENT EVENT WILL BE REPORTED UNDER BOTH THE NAVISTAR THERMOCOOL CATHETERS ((B)(4)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249977 NAVISTAR® THERMOCOOL® CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD BIOSENSE WEBSTER, INC (IRWINDALE) D-1197-16-S UNKNOWN_D-1197-16-S IRW

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R