BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 9194738 · Received October 15, 2019

    Report

    Report Number
    2029046-2019-03762
    Event Type
    Injury
    Date Received
    October 15, 2019
    Date of Event
    September 18, 2019
    Report Date
    September 18, 2019
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    PMA / PMN Number
    P030031/S053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS DISCARDED, THEREFORE NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND DEVICE MALFUNCTION CANNOT BE CONFIRMED.  MANUFACTURING RECORD EVALUATION (MRE) REVIEW CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. MANUFACTURER'S REFERENCE # (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MALE PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A SMART TOUCH BIDIRECTIONAL CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. DURING THE PROCEDURE, THE PATIENT DEVELOPED PERICARDIAL EFFUSION. SURGERY WAS DELAYED DUE TO THE ADVERSE EVENT. IN PHYSICIAN'S OPINION, THIS EVENT WAS RELATED TO TRANSSEPTAL PUNCTURE USING THE DEFLECTABLE SHEATH AGILIS M CURVE (ABBOT), HOWEVER, DURING THE ABLATION PHASE IS WHEN IT WAS NOTICED THAT THE PATIENT¿S BLOOD PRESSURE WAS DROPPING. THE ATRIAL PUNCTURE WAS PERFORMED DURING THE TRANSSEPTAL PHASE. THE PROCEDURE WAS ABORTED SO THAT THE PERICARDIAL EFFUSION COULD BE STOPPED. EXTENDED HOSPITALIZATION WAS REQUIRED. NO ERROR MESSAGES ON BIOSENSE WEBSTER, INC. EQUIPMENT WERE REPORTED. TRANSSEPTAL PUNCTURE WAS PERFORMED WITH A DEFLECTABLE SHEATH AGILIS M CURVE FROM ABBOT MEDICAL. THERE WAS NO EVIDENCE OF A STEAM POP. THE VISITAG MODULE WAS USED WITH THE FOLLOWING SETTINGS: 3SEG, 3MM, 25% TIME, MIN FORCE 3GR. ADDITIONAL FILTERS USED WAS THE ABLATION INDEX. THE FLOW WAS SENT TO 8ML/MIN LESS THAN 25W AND 17ML/MIN MORE THAN 25W. THE SMARTTOUCH CATHETER WAS IN CLOSE PROXIMITY TO THE PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER AND IT WAS ZEROED AFTER THE INITIAL WARM-UP PHASE POST CATHETER CONNECTION TO THE CARTO® 3 PIU. THE CARTO® 3 SYSTEM DID NOT INDICATE TO RE-ZERO THE CATHETER. THE PATIENT WAS UNDER GENERAL ANESTHESIA FOR 3-4 HOURS. ALTHOUGH IT IS UNKNOWN IF ABLATION WAS PERFORMED PRIOR TO DETECTION OF THE EFFUSION, THIS EVENT WILL BE CONSERVATIVELY REPORTED UNDER THE SMART TOUCH BIDIRECTIONAL ABLATION CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    986097 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER SIMILAR DEVICE D132701, PMA # P030031/S053 LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R