BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 7573421 · Received June 6, 2018

    Report

    Report Number
    2029046-2018-01638
    Event Type
    Injury
    Date Received
    June 6, 2018
    Date of Event
    May 11, 2018
    Report Date
    May 11, 2018
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010176
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. 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: ST. JUDE MEDICAL AGILIS DEFLECTABLE SHEATH (MODEL# UNKNOWN, LOT# UNKNOWN), PENTARAY NAV ECO CATHETER (MODEL# K120425, LOT# UNKNOWN), SOUNDSTAR 3D 10F-90 (MODEL# K112050, LOT# UNKNOWN). MANUFACTURER'S REF. NO: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MALE PATIENT UNDERWENT AN ABLATION PROCEDURE FOR ISCHEMIC VENTRICULAR TACHYCARDIA IVT WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND SUFFERED A MEDICAL DEVICE ENTRAPMENT REQUIRING SURGICAL INTERVENTION. TRANSSEPTAL ACCESS WAS OBTAINED VIA A ST. JUDE MEDICAL AGILIS DEFLECTABLE SHEATH. MAPPING WAS INITIATED WITH THE PENTARAY NAV ECO CATHETER. PENTARAY CATHETER WAS REMOVED, SMARTTOUCH SF CATHETER WAS INTRODUCED VIA THE AGILIS SHEATH, AND MAPPING CONTINUED. DURING ABLATION, THE PHYSICIAN INDICATED THAT THE SMARTTOUCH SF CATHETER WAS ENTRAPPED AND COULD NOT BE MANEUVERED. SMARTTOUCH SF CATHETER POSITION WAS CONFIRMED TO BE IN THE MITRAL VALVE APPARATUS VIA SOUNDSTAR INTRACARDIAC ECHOCARDIOGRAPHY (ICE), TRANSTHORACIC ECHOCARDIOGRAPHY (TTE), AND X-RAY. PATIENT WAS REPORTED TO BE IN STABLE CONDITION. PATIENT WAS TRANSFERRED TO THE OPERATING ROOM FOR CARDIOTHORACIC SURGEON SUPPORT. PHYSICIAN SUCCESSFULLY RETRACTED THE SMARTTOUCH SF CATHETER VIA THE FEMORAL VEIN WITHOUT CAUSING DAMAGE TO THE MITRAL VALVE APPARATUS. THERE WERE NO FURTHER COMPLICATIONS. PATIENT DID NOT REQUIRE EXTENDED HOSPITALIZATION AS A RESULT OF THE ADVERSE EVENT. PATIENT FULLY RECOVERED WITH NO RESIDUAL EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416744 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 17749278L 10846835010176

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention