BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 4601798 · Received March 13, 2015

    Report

    Report Number
    9673241-2015-00147
    Event Type
    Injury
    Date Received
    March 13, 2015
    Date of Event
    February 18, 2015
    Report Date
    February 18, 2015
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    PMA / PMN Number
    P030031/S053
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. 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 PRODUCTS: THE CARTO 3 SYSTEM (13255), STOCKERT 70 (ST-4788), COOLFLOW PUMP (HEI05643) MANUFACTURE¿S REFERENCE NO.: (B)(4). THE BWI FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. THE ANALYSIS HAS BEGUN BUT IS NOT COMPLETED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4) IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH BI-DIRECTIONAL NAVIGATION CATHETER AND DEVELOPED CARDIAC TAMPONADE. DURING THE CASE, NON-MDR REPORTABLE MAGNETIC SENSOR ISSUES OCCURRED WHILE USING THE FIRST CATHETER (D132704 ¿ LOT #17111006M ). THE ISSUE WAS RESOLVED BY USING A SECOND SIMILAR LIKE DEVICE, WHICH THEN EXPERIENCED NON-MDR REPORTABLE EPROM ERROR ISSUES (D132704 ¿ LOT #17098284M). THE CATHETER WAS UNPLUGGED AND NOT USED AGAIN. THE TAMPONADE WAS DISCOVERED AFTER USE OF THE SECOND CATHETER (D132704 ¿ LOT #17098284M). BOTH COMPLAINT DEVICES WERE RETURNED TO BWI AND WERE EVALUATED FOR IRRIGATION, CARTO 3 FUNCTIONALITY, STOCKERT COMPATIBILITY, ELECTRICAL PERFORMANCE, TEMPERATURE RESPONSE, AND FORCE SENSOR FUNCTIONALITY. EVALUATION RESULTS FOR THE FIRST CATHETER WHICH EXHIBITED MAGNETIC SENSOR ERRORS (LOT #17111006M): 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 DEFLECTION TEST WAS PERFORMED AND THE CATHETER PASSED. THEN, THE FUNCTIONALITY OF THE SENSOR CATHETER WAS TESTED ON THE CARTO SYSTEM. THE CATHETER FAILED DURING CARTO TESTS, ERROR 106 WAS DISPLAYED. THE CATHETER WAS THEN DISSECTED AND IT WAS DETERMINED THAT THE ROOT CAUSE WAS AN INTERNAL FAILURE OF THE FORCE SENSOR. THE CATHETER FAILED DURING THE FORCE SENSOR TEST, HOWEVER THE ROOT CAUSE OF THE TAMPONADE 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. EVALUATION RESULTS FOR THE SECOND CATHETER THAT EXHIBITED EEPROM ERRORS (LOT #17098284M): THE RETURNED DEVICE WAS VISUALLY INSPECTED UPON RECEIPT AND IT WAS FOUND IN NORMAL CONDITIONS. PER THE EVENT, AN IRRIGATION TEST WAS PERFORMED AND THE CATHETER PASSED, NO OCCLUSION WAS OBSERVED. A DEFLECTION TEST WAS PERFORMED AND THE CATHETER PASSED. THE CATHETER WAS ALSO EVALUATED FOR CARTO 3 FUNCTIONALITY. THE CATHETER WAS RECOGNIZED BY THE CARTO 3 SYSTEM, NO ERROR MESSAGES WERE DISPLAYED AND THE CATHETER WAS PROPERLY VISUALIZED. THE FORCE FEATURE WAS EVALUATED AND PASSED. THE CATHETER WAS TESTED FOR ELECTRICAL PERFORMANCE, TEMPERATURE RESPONSE AND STOCKERT COMPATIBILITY AND FAILED DURING THE ELECTRICAL TEST. FURTHER EXAMINATION REVEALED THAT LEAD WIRE #5 WAS BROKEN, CAUSING THE IMPROPER SIGNAL CONDITION. THE CATHETER FAILED DURING ELECTRICAL TEST; HOWEVER THE ROOT CAUSE OF THE TAMPONADE 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 REPORTED THAT A MALE PATIENT, (B)(6), UNDERWENT AN ATRIAL FIBRILLATION PROCEDURE WITH A THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER AND DEVELOPED CARDIAC TAMPONADE. DURING THE CASE, A MAGNETIC SENSOR ERROR OCCURRED THAT WAS RESOLVED WITH A SIMILAR-LIKE DEVICE. AFTER THE COMPLETION OF THE PROCEDURE, THE PHYSICIAN IDENTIFIED A TAMPONADE AS CONFIRMED WITH ICE. A PERICARDIALCENTESIS WAS PERFORMED AND 600 CC OF FLUID WAS REMOVED FROM THE PERICARDIAL SPACE. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION AT THE TIME THE COMPLAINT WAS REPORTED. THE PHYSICIAN DID NOT PROVIDE A CAUSALITY OPINION FOR THE CAUSE OF THIS ADVERSE EVENT, ALTHOUGH HE DID EXPRESS CONCERN WITH THE TRANSEPTAL PUNCTURE THAT WAS PERFORMED DURING THE CASE. THIS ADVERSE EVENT IS CONSIDERED TO BE SERIOUS AND MDR REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173864 THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1327-04-S 17098284M

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Life Threatening| R