BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 8587929 · Received May 7, 2019

    Report

    Report Number
    2029046-2019-03079
    Event Type
    Injury
    Date Received
    May 7, 2019
    Date of Event
    April 9, 2019
    Report Date
    April 9, 2019
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010183
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    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 MANUFACTURING RECORD EVALUATION (MRE) CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. CONCOMITANT PRODUCTS: PENTARAY NAVIGATIONAL ECO CATHETER, US CATALOG #: D128208, LOT #: UNKNOWN. CARTO 3 SYSTEM, US CATALOG #: FG540000, SERIAL #: (B)(4). SMARTABLATE GENERATOR, US CATALOG #: UNKNOWN, SERIAL #: UNKNOWN. SMARTABLATE PUMP, US CATALOG #: UNKNOWN, SERIAL #: UNKNOWN. NON BIOSENSE WEBSTER, INC. PRODUCT: ST. JUDE MEDICAL BRK1 XS TRANSSEPTAL NEEDLE. NON BIOSENSE WEBSTER, INC. PRODUCT: AGILIS MED CURL 8.5 FR SHEATH. MANUFACTURER'S REF. NO: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6)-YEAR-OLD FEMALE PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND SUFFERED CARDIAC PERFORATION REQUIRING NO INTERVENTIONS. DURING THE PROCEDURE SINGLE TRANSSEPTAL APPROACH WAS PERFORMED TO INTRODUCE THE THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER TO THE LEFT SIDE OF THE HEART, WHEN ADVANCING THE CATHETER CARDIAC PERFORATION OCCURRED. PERICARDIAL EFFUSION WAS NOTED, THE PATIENT WAS IN STABLE CONDITION. NO MEDICAL/SURGICAL INTERVENTION WAS PERFORMED. EXTENDED HOSPITALIZATION WAS NOT REQUIRED AS A RESULT OF THE EVENT. PATIENT¿S OUTCOME IS FULLY RECOVERED WITH NO RESIDUAL EFFECTS. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT OCCURRED DUE TO THE EXCESSIVE FORCE APPLIED. THERE WERE NO FACTORS CITED SUCH AS PATIENT¿S ANATOMY OR DISEASE CITED THAT MIGHT HAVE CONTRIBUTED TO THE ADVERSE EVENT. NO ERROR MESSAGES WERE OBSERVED ON ANY BWI EQUIPMENT DURING THE PROCEDURE. TRANSSEPTAL PUNCTURE WAS PERFORMED WITH A ST. JUDE MEDICAL BRK1 XS TRANSSEPTAL NEEDLE. AN AGILIS MED CURL 8.5 FR SHEATH WAS USED DURING THE CASE. THE GENERATOR PARAMETERS INCLUDED POWER AT 35 WATTS TIME 999 SECONDS. NO ABLATION WAS PERFORMED PRIOR TO THE ADVERSE EVENT. THE PATIENT RECEIVED ANTICOAGULANT DURING THE CASE WITH AN ACTIVATED CLOTTING TIME (ACT) BETWEEN 300-350 SECONDS. THE THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER WAS NOT IN CLOSE PROXIMITY TO ANOTHER CATHETER AND IT WAS ZEROED AFTER THE INITIAL WARM-UP PHASE POST CATHETER CONNECTION TO THE CARTO 3 PATIENT INTERFACE UNIT (PIU). THE CARTO 3 SYSTEM DID NOT INDICATE TO RE-ZERO THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382586 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Life Threatening