BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMARTTOUCH® SF BI-DIRECTIONAL NAV CATHETER

    MDR report key: 5548290 · Received April 5, 2016

    Report

    Report Number
    9673241-2016-00222
    Event Type
    Injury
    Date Received
    April 5, 2016
    Date of Event
    March 1, 2016
    Report Date
    March 14, 2016
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS DISCARDED, THEREFORE NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND DEVICE MALFUNCTION CANNOT BE CONFIRMED. SINCE NO LOT NUMBER WAS PROVIDED, NO DEVICE HISTORY RECORD (DHR) REVIEW COULD BE PERFORMED. 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 PMA # P030031/S053. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE FOR ATRIAL FIBRILLATION WITH A THERMOCOOLSMARTTOUCHSF BI-DIRECTIONAL NAV CATHETER AND SUFFERED A THROMBOSIS. IT IS UNKNOWN IF THERE WAS A MEDICAL OR SURGICAL INTERVENTION PROVIDED. ABLATION PROCEDURE WAS COMPLETED WITHOUT COMPLICATION. AFTER PROCEDURE COMPLETION, THROMBOSIS WAS IDENTIFIED. IT WAS REPORTED THAT THE ACCOUNT NORMALLY USES A SMARTTOUCH AND NOT AN SF CATHETER. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204690 THERMOCOOL® SMARTTOUCH® SF BI-DIRECTIONAL NAV CATHETER SIMILAR DEVICE D132701, PMA # P030031/S053 LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1348-05-S UNKNOWN_D-1348-05-S

    Patients

    Seq Age Sex Outcome Treatment
    1 Other