BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 7766249 · Received August 9, 2018

    Report

    Report Number
    2029046-2018-01927
    Event Type
    Injury
    Date Received
    August 9, 2018
    Date of Event
    July 10, 2018
    Report Date
    July 10, 2018
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    PMA / PMN Number
    P030031/S053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, 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. DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. CONCOMITANT PRODUCT: CARTO 3 SYSTEM, US CATALOG #: UNKNOWN, SERIAL #: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FLUTTER LEFT (L-AFL) ABLATION PROCEDURE WITH AN UNKNOWN THERMOCOOL SMART TOUCH BI-DIRECTIONAL NAVIGATION CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. POST-PROCEDURE, CARDIAC TAMPONADE WAS CONFIRMED. PERICARDIOCENTESIS WAS PERFORMED TO REMOVE 500ML OF BLOOD FROM THE PERICARDIUM. EXTENDED HOSPITALIZATION WAS REQUIRED AS A RESULT OF THE ADVERSE EVENT TO EVALUATE THE PATIENT OVER NIGHT FOR SAFETY. PATIENT OUTCOME WAS IMPROVED. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT WAS THAT IT WAS PROCEDURE-RELATED. THERE WERE NO ISSUES OR ERRORS REPORTED ON ANY BIOSENSE WEBSTER, INC. PRODUCTS OR EQUIPMENT ON THE EVENT DESCRIPTION. TRANSSEPTAL PUNCTURE WAS PERFORMED WITH AN UNKNOWN TRANSSEPTAL NEEDLE AND AN UNKNOWN SHEATH. THE GENERATOR WAS IN POWER CONTROL MODE. THE OVERALL TIME FOR ABLATION AT THE SITE OF INJURY WAS OVER TEN MINUTES OF ABLATION PERFORMED IN THE RIGHT AND LEFT ATRIUM. THE LAST ABLATION CYCLE TIME IS UNKNOWN. THE CATHETER IRRIGATION WAS SET ON SLOW FLOW AT 2ML/MIN, 8ML/MIN WHEN APPLYING LOW POWER AND 15ML/MIN WHEN APPLYING HIGH POWER. THE THERMOCOOL SMART TOUCH BI-DIRECTIONAL NAVIGATION CATHETER WAS NOT IN CLOSE PROXIMITY TO ANOTHER CATHETER. IT WAS ZEROED AFTER THE INITIAL WARM-UP PHASE POST CATHETER CONNECTION TO THE CARTO 3 PATIENT INTEFACE UNIT. THE CARTO 3 SYSTEM DID NOT INDICATE TO RE-ZERO THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611907 THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER SIMILAR DEVICE D132701, PMA # P030031/S053 LPB BIOSENSE WEBSTER INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R