BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER

    MDR report key: 6068199 · Received October 31, 2016

    Report

    Report Number
    9673241-2016-00750
    Event Type
    Death
    Date Received
    October 31, 2016
    Date of Event
    October 7, 2016
    Report Date
    October 7, 2016
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    UDI-DI
    10846835003147
    PMA / PMN Number
    P030031/S025
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT AN IDIOPATHIC LEFT VENTRICULAR TACHYCARDIA ABLATION PROCEDURE FOR PREMATURE VENTRICULAR CONTRACTIONS AND PERSISTENT ATRIAL FIBRILLATION WITH AN EZ STEER THERMOCOOL SF NAV CATHETER AND SUFFERED A VASCULAR DISSECTION RESULTING IN THE PATIENT¿S DEATH. THE RETURNED DEVICE WAS VISUALLY INSPECTED AND WAS FOUND IN GOOD CONDITION. PER THE EVENT, THE CATHETER WAS TESTED FOR ELECTRICAL PERFORMANCE, TEMPERATURE RESPONSE AND GENERATOR COMPATIBILITY, AND IT WAS FOUND WITHIN SPECIFICATIONS. THE CATHETER WAS EVALUATED FOR EEPROM, AND SENSOR FUNCTIONALITY WAS TESTED ON A CARTO 3 SYSTEM. THE CATHETER WAS RECOGNIZED BY CARTO 3 SYSTEM WITH NO ERROR MESSAGES AND PROPER VISUALIZATION. EEPROM DATA DEMONSTRATES THAT THE CATHETER WAS PROPERLY CALIBRATED DURING MANUFACTURING. THE FORCE FEATURE WAS EVALUATED AND PASSED. AN IRRIGATION TEST WAS PERFORMED, WHICH THE CATHETER PASSED. NO OCCLUSION WAS OBSERVED. FINALLY, THE CATHETER WAS TESTED FOR DEFLECTION, AND WAS FOUND TO BE WORKING PROPERLY. HOWEVER, DURING THE DEFLECTION TEST, THE PULLER WIRE INSIDE THE HANDLE BROKE. 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 FAILED THE DEFLECTION TEST. HOWEVER, THIS FAILURE OCCURRED DURING FAILURE ANALYSIS. THUS, THE DEFLECTION FAILURE COULD NOT HAVE CONTRIBUTED TO THE DEATH. AS A RESULT, THE ROOT CAUSE OF THE DEATH REMAINS UNKNOWN. THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED.

    Additional Manufacturer Narrative · 1

    SINCE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. AS SUCH, THE INVESTIGATION WILL BE CLOSED. IF THE COMPLAINT DEVICE IS RECEIVED IN THE FUTURE WE WILL REOPEN THE COMPLAINT AND PERFORM THE INVESTIGATION AS APPROPRIATE. 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. CONCOMITANT MEDICAL PRODUCTS: CARTO 3 SYSTEM, MODEL # M-4800-01, S/N: (B)(4); SMARTABLATE GENERATOR, MODEL AND SERIAL NUMBERS UNKNOWN; SMARTABLATE PUMP, MODEL AND SERIAL NUMBERS UNKNOWN; EZ STEER THERMOCOOL SF NAV CATHETER, MODEL # D-1313-07-S, LOT # 17323864L; WEBSTER QUADRAPOLAR CATHETER, MODEL # D-1086-729-S, LOT # 17527326M. (B)(4).

    Additional Manufacturer Narrative · 1

    ON 11/4/2016, THE BWI FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. THE ANALYSIS HAS BEGUN BUT IS NOT COMPLETED AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT AN IDIOPATHIC LEFT VENTRICULAR TACHYCARDIA ABLATION PROCEDURE FOR PREMATURE VENTRICULAR CONTRACTIONS AND PERSISTENT ATRIAL FIBRILLATION WITH AN EZ STEER THERMOCOOL SF NAV CATHETER AND SUFFERED A VASCULAR DISSECTION RESULTING IN THE PATIENT'S DEATH. DURING THE PROCEDURE, THE PATIENT DEVELOPED AN AORTIC DISSECTION. PATIENT WAS TAKEN TO THE OPERATING ROOM FOR SURGICAL REPAIR OF THE AORTA. PATIENT EXPIRED DURING SURGICAL PREPARATION. THERE IS NO INFORMATION REGARDING AN AUTOPSY. PHYSICIAN'S OPINION REGARDING THE CAUSE OF DEATH IS THAT IT WAS SECONDARY TO AN AORTIC DISSECTION THAT OCCURRED WHILE CROSSING THE VALVE WITH THE ABLATION CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    717201 THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1313-07-S 17323864L 10846835003147

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death