BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL® SMARTTOUCH® SF BI-DIRECTIONAL NAV CATHETER

    MDR report key: 4746239 · Received May 4, 2015

    Report

    Report Number
    9673241-2015-00254
    Event Type
    Malfunction
    Date Received
    May 4, 2015
    Date of Event
    April 8, 2015
    Report Date
    April 13, 2015
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

    (B)(4) IT WAS REPORTED THAT AT THE END OF PULMONARY VEIN ISOLATION (PVI) WITH CARTO IN A LIMITED MARKET RELEASE (LMR) CASE, THE PHYSICIAN NOTICED A CHAR ON THE TIP OF THE CATHETER. AFTER FOLLOWING UP, IT WAS CONFIRMED THAT THE MATERIAL APPEARED ON TIP OF CATHETER WAS COAGULUM, MAKING THIS EVENT REPORTABLE UPON RECEIPT, THE CATHETER WAS VISUALLY INSPECTED AND TIP DOME HAS LIGHT REDDISH BROWN MATERIAL ON IT. PER THE EVENT, THE CATHETER WAS TESTED FOR ELECTRICAL PERFORMANCE, TEMPERATURE RESPONSE AND STOCKERT COMPATIBILITY AND IT WAS FOUND WITHIN SPECIFICATIONS. ALSO AN IRRIGATION TEST WAS PERFORMED AND THE CATHETER PASSED, NO OCCLUSION WAS OBSERVED. HOWEVER THE ROOT CAUSE OF THE CHAR REMAINS UNKNOWN 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 CUSTOMER COMPLAINT HAS BEEN CONFIRMED.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 [SMART TOUCH] APPROVED UNDER [P030031/S053]. 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT THE END OF PULMONARY VEIN ISOLATION (PVI) WITH CARTO IN A LIMITED MARKET RELEASE (LMR) CASE, THE PHYSICIAN NOTICED A CHAR ON THE TIP OF THE CATHETER. AFTER FOLLOWING UP, IT WAS CONFIRMED THAT THE MATERIAL APPEARED ON TIP OF CATHETER WAS COAGULUM, MAKING THIS EVENT REPORTABLE. THERE WAS NO INDICATION OF ANY PROBLEM DURING THE PROCEDURE AND THE PROCEDURE COMPLETED WITHOUT ANY PATIENT CONSEQUENCES. THE SYSTEM DID NOT PRESENT ANY ERROR MESSAGES AND THE GENERATOR SETTING WAS IN POWER CONTROL MODE, AT 30 WATTS. DURING RF APPLICATION, THE TEMPERATURE WAS BETWEEN 31-33 DEGREES; IMPEDANCE WAS BETWEEN 142 - 155 OHMS. IT WAS CONFIRMED THAT THE PATIENT HAS NOT EXHIBITED ANY NEUROLOGICAL SYMPTOMS SINCE THE PROCEDURE WAS COMPLETED. IT WAS STATED THAT THE PHYSICIAN DID NOT HAVE ANY CONCERN ABOUT THE AMOUNT OF COAGULUM ON THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290678 THERMOCOOL® SMARTTOUCH® SF BI-DIRECTIONAL NAV CATHETER SIMILAR DEVICE D132701, PMA # P030031/S053 LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1348-05-S 17111287L

    Patients

    Seq Age Sex Outcome Treatment
    1