BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 8673260 · Received June 6, 2019

    Report

    Report Number
    2029046-2019-03240
    Event Type
    Death
    Date Received
    June 6, 2019
    Date of Event
    May 10, 2019
    Report Date
    May 15, 2019
    Manufacturer
    BIOSENSE WEBSTER INC.
    Product Code
    LPB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURING RECORD EVALUATION CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. MANUFACTURER'S REF. # (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FEMALE PATIENT OF ABOUT (B)(6) YEARS-OLD ((B)(6) KG) UNDERWENT AN ABLATION PROCEDURE FOR PERSISTENT ATRIAL FIBRILLATION WITH A THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER AND A STOCKERT GENERATOR AND SUFFERED ESOPHAGEAL FISTULA THAT LED TO DEATH. POST-PROCEDURE, THE PATIENT DEVELOPED ESOPHAGEAL FISTULA. PERFORATION WAS NOT DETECTED DURING THE PROCEDURE. NO MEDICAL/SURGICAL INTERVENTION WAS PERFORMED. EXTENDED HOSPITALIZATION WAS REQUIRED DUE TO THE PATIENT HAVING EPILEPTIC ATTACKS. THE PATIENT EXPIRED ON (B)(6) 2019. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS PATIENT CONDITION RELATED, THE PATIENT HAD A COMPLEX CLINICAL BACKGROUND THAT CONTRIBUTED TO THE CLINICAL COMPLICATION; OVERWEIGHT, DIABETES AND ESPECIALLY SARCOIDOSIS. ESOPHAGEAL INJURY CONFIRMED WITH AUTOPSY. THE STOCKERT GENERATOR WAS USED IN POWER CONTROL MODE WITH A TEMPERATURE CUT-OFF AT 50 DEGREES. NO ERROR MESSAGES WERE OBSERVED ON ANY BWI EQUIPMENT DURING THE PROCEDURE. THE FORCE VISUALIZATION FEATURES USED INCLUDED GRAPH, DASHBOARD, VECTOR AND VISITAG. THE PARAMETERS FOR STABILITY USED WITH THE VISITAG MODULE WERE 3 MM, TIME: 3S, FORCE OVER TIME: 25%, 3G. THE COLOR OPTION USED PROSPECTIVELY WAS TAG INDEX (380 POSTERIOR, 500 ANTERIOR). THE CARTO® 3 SYSTEM DID NOT INDICATE TO RE-ZERO THE THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER. BIOSENSE WEBSTER MANUFACTURER'S REFERENCE NUMBER (B)(4) HAS TWO REPORTS RELATED TO THE SAME EVENT: MFR # 2029046-2019-03240 FOR PRODUCT CODE D132700 (THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER). MFR # 2029046-2019-03241 FOR PRODUCT CODE 39D76X (STOCKERT GENERATOR).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468457 THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER SIMILAR DEVICE D132701, PMA # P030031/S053 LPB BIOSENSE WEBSTER INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death CARTO 3 SYSTEM