BEUDAMED
    FDA Adverse Event Death Summary report: N

    SMARTABLATE GENERATOR KIT-US

    MDR report key: 7460304 · Received April 25, 2018

    Report

    Report Number
    2029046-2018-01471
    Event Type
    Death
    Date Received
    April 25, 2018
    Date of Event
    February 13, 2018
    Report Date
    March 27, 2018
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    04260166371390
    PMA / PMN Number
    P990071/S017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HARDWARE INVESTIGATION HAS BEGUN BUT IT HAS NOT BEEN COMPLETED AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. BIOSENSE WEBSTER MANUFACTURER'S REFERENCE (B)(4) HAS TWO COMPLAINTS THAT ARE RELATED TO THE SAME INCIDENT. (B)(4).

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: IT WAS REPORTED THAT A (B)(6) MALE PATIENT UNDERWENT AN ABLATION PROCEDURE FOR ATRIAL FIBRILLATION WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND A SMARTABLATE¿ SYSTEM RF GENERATOR (US) AND SUFFERED AN ESOPHAGEAL FISTULA (REQUIRING UPPER GI IMAGING AND BLOOD PRODUCTS) AND DEATH. APPROXIMATELY 1 MONTH POST-PROCEDURE, AN ATRIOESOPHAGEAL FISTULA WAS CONFIRMED VIA UPPER GI IMAGING. BLOOD PRODUCTS WERE ADMINISTERED. PATIENT REQUIRED EXTENDED HOSPITALIZATION AS A RESULT OF THE ADVERSE EVENT. AT AN UNSPECIFIED POINT, THE PATIENT EXPIRED. REPAIR FOLLOW-UP WAS PERFORMED AND DEVICE WAS NOT SHIPPED FOR SERVICE. SERVICE WAS DECLINED. THE DEVICE HISTORY RECORD (DHR) REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. NO MALFUNCTION FOUND ON THE DEVICE. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) MALE PATIENT UNDERWENT AN ABLATION PROCEDURE FOR ATRIAL FIBRILLATION WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND A SMARTABLATE¿ SYSTEM RF GENERATOR (US) AND SUFFERED AN ESOPHAGEAL FISTULA (REQUIRING UPPER GI IMAGING AND BLOOD PRODUCTS) AND DEATH. APPROXIMATELY 1 MONTH POST-PROCEDURE, AN ATRIOESOPHAGEAL FISTULA WAS CONFIRMED VIA UPPER GI IMAGING. BLOOD PRODUCTS WERE ADMINISTERED. PATIENT REQUIRED EXTENDED HOSPITALIZATION AS A RESULT OF THE ADVERSE EVENT. AT AN UNSPECIFIED POINT, THE PATIENT EXPIRED. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS PROCEDURE-RELATED. IT WAS NOTED THAT ESOPHAGEAL FISTULA IS A KNOWN COMPLICATION OF THE PROCEDURE. THERE WERE NO ISSUES OR ERRORS REPORTED ON ANY BIOSENSE WEBSTER, INC. PRODUCTS OR EQUIPMENT DURING THE PROCEDURE. GENERATOR WAS SET ON POWER CONTROL MODE AT 30 WATTS AND 37 DEGREES CELSIUS WITH IMPEDANCE OF 95-130 OHMS. THERE IS NO INFORMATION REGARDING OVERALL ABLATION TIME OR LAST ABLATION CYCLE TIME AT THE SITE OF INJURY. ESOPHAGEAL INJURY PREVENTION MODALITIES INCLUDED AN ESOPHAGEAL TEMPERATURE PROBE FOR USE DURING POSTERIOR WALL ABLATION. SHAFT PROXIMITY INTERFERENCE VALUE WAS REPORTED TO BE WITHIN NORMAL LIMITS. THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER WAS NOT IN CLOSE PROXIMITY TO ANOTHER CATHETER. THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER WAS ZEROED AFTER THE INITIAL WARM-UP PHASE POST CATHETER CONNECTION TO THE CARTO 3 PATIENT INTERFACE UNIT. CARTO 3 SYSTEM DID NOT INDICATE TO RE-ZERO THE CATHETER. THERE WERE NO ISSUES OR ERRORS OBSERVED ON ANY BWI PRODUCTS OR EQUIPMENT DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302002 SMARTABLATE GENERATOR KIT-US CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 04260166371390

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death| H| R