BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMARTTOUCH® SF BI-DIRECTIONAL NAV CATHETER

    MDR report key: 6571177 · Received May 16, 2017

    Report

    Report Number
    9673241-2017-00378
    Event Type
    Injury
    Date Received
    May 16, 2017
    Date of Event
    March 22, 2017
    Report Date
    May 15, 2017
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    UDI-DI
    10846835010183
    PMA / PMN Number
    P030031
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE WAS RECEIVED FOR ANALYSIS AT THE TIME OF SUBMISSION OF THE INITIAL 3500A. 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. THE DEVICE HISTORY RECORD (DHR) FOR THE LOT NUMBER 17623373L HAS BEEN REVIEWED AND IT WAS VERIFIED THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATIONS AND PROCEDURES. (B)(4).

    Additional Manufacturer Narrative · 1

    ON 5/17/2017, IT WAS DISCOVERED THAT THIS COMPLAINT FILE IS A DUPLICATE OF REPORT #9673241-2017-00367 ((B)(4)). AS A RESULT, SOME ADDITIONAL INFORMATION HAS BECOME AVAILABLE. THE COMPLAINT DEVICE WAS DISPOSED OF, THE PATIENT WAS A (B)(6) MALE, AND THE PROCEDURE WAS FOR PERSISTENT ATRIAL FIBRILLATION. THE PRODUCT WAS DISCARDED, THEREFORE NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND DEVICE MALFUNCTION CANNOT BE CONFIRMED. 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: BOSTON SCIENTIFIC DIREX STEERABLE 10FR SHEATH, M004 DS40S 0. (B)(4).

    Description of Event or Problem · 1

    DURING A CLINICAL TRIAL SPONSORED BY BIOSENSE WEBSTER, INC., IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH BI-DIRECTIONAL SF CATHETER AND SUFFERED AN ARTERIOVENOUS FISTULA REQUIRING SURGICAL INTERVENTION. DURING THE PROCEDURE, ARTERIAL PULSATIONS WERE DETECTED IN THE VEIN, INDICATING HIGH TURBULENT FLOW BETWEEN THE VEIN AND THE ARTERY. PATIENT WAS DIAGNOSED WITH AN ARTERIOVENOUS FISTULA AFFECTING THE DISTAL COMMON FEMORAL ARTERY. PATIENT WAS TRANSFERRED TO THE OPERATING ROOM FOR SURGICAL REPAIR. PATIENT REQUIRED EXTENDED HOSPITALIZATION (3 ADDITIONAL DAYS) AS A RESULT OF THE ADVERSE EVENT. ISSUE RESOLVED WITHOUT SEQUELAE. PRINCIPAL INVESTIGATOR ASSESSED THIS EVENT AS MODERATE IN SEVERITY, SERIOUS, NOT STUDY DEVICE-RELATED, AND DEFINITELY INDEX PROCEDURE-RELATED. SINCE THIS ADVERSE EVENT REQUIRED MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE, IT IS TO BE CONSIDERED SERIOUS AND MDR REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352565 THERMOCOOL® SMARTTOUCH® SF BI-DIRECTIONAL NAV CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1348-05-S 17623373L 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R