BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMARTTOUCH® SF UNI-DIRECTIONAL NAV CATHETER

    MDR report key: 5488175 · Received March 8, 2016

    Report

    Report Number
    9673241-2016-00176
    Event Type
    Injury
    Date Received
    March 8, 2016
    Date of Event
    November 30, 2015
    Report Date
    December 1, 2015
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT A (B)(6) MALE PATIENT UNDERWENT AN ABLATION PROCEDURE FOR ATRIAL FIBRILLATION WITH A THERMOCOOL® SMARTTOUCH® SF UNI-DIRECTIONAL NAV CATHETER AND SUFFERED PULMONARY VEIN STENOSIS AND THROMBOSIS. THE RETURNED DEVICE WAS VISUALLY AND IT WAS FOUND IN NORMAL CONDITIONS. PER THE EVENT, THE CATHETER WAS TESTED FOR ELECTRICAL PERFORMANCE, TEMPERATURE RESPONSE AND GENERATOR TEST AND IT WAS FOUND WITHIN SPECIFICATIONS. A DEFLECTION TEST WAS PERFORMED AND THE CATHETER PASSED. THE CATHETER WAS EVALUATED FOR EEPROM, AND THE FUNCTIONALITY OF THE SENSORS OF THE CATHETER WAS TESTED ON CARTO SYSTEM. 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. THE FORCE FEATURE WAS EVALUATED AND PASSED. AN IRRIGATION TEST WAS PERFORMED AND THE CATHETER PASSED, NO OCCLUSION WAS OBSERVED. 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. BASED ON AVAILABLE ANALYSIS FINDING RESULTS, THE FAILURE MODE DOES NOT APPEAR TO BE CAUSED BY ANY INTERNAL BWI PROCESSES. THE ROOT CAUSE OF THE TEMPERATURE FAILURE, PULMONARY VEIN STENOSIS AND THROMBOSIS REMAINS UNKNOWN.

    Additional Manufacturer Narrative · 1

    THE ¿SUSPECTED MEDICAL DEVICE¿ REPORTED IN THIS REPORT IS NOT MARKETED IN USA OR APPROVED BY THE FDA. HOWEVER, IT IS BEING REPORTED AS BIOSENSE WEBSTER CONSIDERS THIS AS A SIMILAR DEVICE TO THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER APPROVED UNDER P030031/S053. (B)(4). BIOSENSE WEBSTER MANUFACTURER'S REF. NO.'S (B)(4) ARE RELATED TO THE SAME INCIDENT. THE RETURNED DEVICE WAS VISUALLY INSPECTED AND IT WAS FOUND IN NORMAL CONDITIONS. THE CATHETER WAS TESTED FOR ELECTRICAL PERFORMANCE, TEMPERATURE RESPONSE AND STOCKERT COMPATIBILITY AND IT WAS FOUND WITHIN SPECIFICATIONS. AN IRRIGATION TEST WAS PERFORMED AND THE CATHETER PASSED, NO OCCLUSION WAS OBSERVED. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO ANOMALIES WERE FOUND. IN ADDITION, THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. THE ROOT CAUSE OF THE THROMBOSIS AND PULMONARY VEIN STENOSIS REMAINS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) MALE PATIENT UNDERWENT AN ABLATION PROCEDURE FOR ATRIAL FIBRILLATION WITH A THERMOCOOL® SMARTTOUCH® SF UNI-DIRECTIONAL NAV CATHETER AND SUFFERED PULMONARY VEIN STENOSIS AND THROMBOSIS. AT THE BEGINNING OF THE PROCEDURE, THE TEMPERATURE INCREASED SUDDENLY WHEN PRESSING THE RADIOFREQUENCY (RF) PEDAL. THE RF GENERATOR CUT-OFF AND IT WAS IMPOSSIBLE TO CONTINUE ABLATION. THE CATHETER WAS REPLACED AND THE ISSUE RESOLVED. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT CONSEQUENCE. THIS EVENT WAS ORIGINALLY ASSESSED AS NOT MDR REPORTABLE BECAUSE THE POTENTIAL THAT IT COULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, OR OTHER SIGNIFICANT ADVERSE EVENT, IS REMOTE. POST-PROCEDURE, THE PATIENT RETURNED TO THE HOSPITAL ON (B)(6) 2016 WITH DYSPNEA AND CHEST PAIN ASSOCIATED WITH BREATHING. AN ANGIOGRAPHY REVEALED LEFT INFERIOR PULMONARY VEIN PREOSTIAL STENOSIS AND LEFT SUPERIOR PULMONARY VEIN THROMBOSIS. THE PATIENT¿S CONDITION IS NOW BETTER DESPITE AN ADVERSE EVENT RELATED TO ANTICOAGULATION. THERE IS NO FURTHER INFORMATION ABOUT ANY ADDITIONAL INTERVENTION PERFORMED. THE PATIENT LEFT THE HOSPITAL ON (B)(6) 2016. THE PHYSICIAN DID NOT PROVIDE CAUSALITY OPINION FOR THE EVENT. THE AWARENESS DATE FOR THIS RECORD IS FEBRUARY 17, 2016 BECAUSE THAT IS WHEN THE PATIENT UPDATE INFORMATION WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143684 THERMOCOOL® SMARTTOUCH® SF UNI-DIRECTIONAL NAV CATHETER SIMILAR DEVICE D133601, PMA # P030031/S053 LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1347-02-S 17169891L

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization