BEUDAMED
    FDA Adverse Event Death Summary report: N

    SMARTABLATE GENERATOR KIT-WW

    MDR report key: 7783180 · Received August 14, 2018

    Report

    Report Number
    2029046-2018-01952
    Event Type
    Death
    Date Received
    August 14, 2018
    Report Date
    July 16, 2018
    Manufacturer
    BIOSENSE WEBSTER INC.
    Product Code
    LPB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 3/22/2019, THE DATE OF DEATH WAS PROVIDED AS (B)(6) 2018. DATE OF DEATH FIELD HAS BEEN POPULATED. ON 4/2/2019, ADDITIONAL EVENT AND PATIENT INFORMATION WAS RECEIVED INDICATING THE (B)(6) YEAR-OLD FEMALE PATIENT HAD A HISTORY OF TYPE I DIABETES MELLITUS, AF AND STROKE. ON POST-PROCEDURE WEEK FOUR, THE PATIENT DEVELOPED SEPSIS AND HEMATEMESIS AND WAS ADMITTED INTO A DIFFERENT HOSPITAL. GASTROSCOPY WAS PERFORMED TO IDENTIFY A CAUSE OF BLEEDING IN THE UPPER GASTROINTESTINAL (GI) TRACT, NO OBVIOUS SOURCE WAS FOUND. PATIENT THEN UNDERWENT CT SCANS OF THE BRAIN AND CHEST TO INVESTIGATE THE POSSIBILITY OF AN ATRIO-ESOPHAGEAL FISTULA. CT SCANS DID NOT SHOW AIR IN THE HEART OR BRAIN. ENDOSCOPY WAS PERFORMED AND REVEAL AN ESOPHAGEAL ULCER. ABLATION INDEX WAS USED TO GUIDE THE OPERATOR. MANUFACTURER¿S REF # (B)(4).

    Additional Manufacturer Narrative · 1

    MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION ON WHICH SYSTEM WAS USED DURING THIS PROCEDURE. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. SINCE THERE IS NO CLARIFICATION, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING CLARIFICATION OF THE SYSTEM USED IN THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. SINCE NO SERIAL NUMBER WAS PROVIDED, NO DEVICE HISTORY RECORD (DHR) REVIEW COULD BE PERFORMED. NOTE: BWI IS STILL CONDUCTING FOLLOW-UP FOR CLARIFICATION OF DATE OF EVENT AND DATE OF DEATH. A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION IS RECEIVED. CONCOMITANT BWI PRODUCTS: THERMOCOOL SMART TOUCH CATHETER (CATALOG # D133602/ LOT # 17769804M); LASSO 2515 NAV VARIABLE CATHETER (LOT # 30018760L); SMARTABLATE IRRIGATION TUBING SET (LOT # C4003257); EXTERNAL REFERENCE PATCHES (LOT # LL015723) MEDICAL DEVICES: NON-BWI CONCOMITANT PRODUCTS: ST. JUDE MEDICAL BRK-1 TRANSSEPTAL NEEDLE 1.3 MM; ST. JUDE MEDICAL SWARTZ SL0 BRAIDED TRANSSEPTAL GUIDING INTRODUCER 8.5 FR; ST. JUDE MEDICAL SWARTZ SL0 BRAIDED TRANSSEPTAL GUIDING INTRODUCER 8 FR; ST. JUDE MEDICAL SWARTZ SL3 BRAIDED TRANSSEPTAL GUIDING INTRODUCER 8 FR; ST. JUDE MEDICAL LIVEWIRE ELECTROPHYSIOLOGY CATHETER 6FR; FIAB SPA ELECTROSURGICAL DISPOSABLE GROUND PATCH. BIOSENSE WEBSTER MANUFACTURER'S REFERENCE NUMBER (B)(4) HAS TWO REPORTS RELATED TO THE SAME INCIDENT: (1) MFR # 2029046-2018-01947 FOR PRODUCT CODE D133602 (THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER); (2) MFR # 2029046-2018-01952 FOR PRODUCT CODE M4900107 (SMARTABLATE GENERATOR KIT-WW).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A PULMONARY VEIN ISOLATION (PVI) ABLATION PROCEDURE FOR PERSISTENT ATRIAL FIBRILLATION AND FLUTTER WITH A THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER AND SMARTABLATE GENERATOR KIT-WW AND SUFFERED ESOPHAGEAL FISTULA THAT LED TO PATIENT¿S DEATH. THE PATIENT WAS ADMITTED IN THE HOSPITAL FOR A PLANNED ABLATION PROCEDURE. SHE PRESENTED IN RATE-CONTROLLED ATRIAL FLUTTER. THE PHYSICIAN ABLATED TO SINUS RHYTHM AND WENT INTO COMPLETE PULMONARY VEIN ISOLATION (PVI). THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY IMMEDIATE COMPLICATION. THE PATIENT WAS DISCHARGED LATER THE SAME DAY. ON POST-PROCEDURE WEEK FOUR, THE PATIENT DEVELOPED AN UPPER GASTROINTESTINAL (GI) BLEED AND WAS ADMITTED INTO A DIFFERENT HOSPITAL. ENDOSCOPY WAS PERFORMED AND REVEAL AN ESOPHAGEAL ULCER. THE PATIENT EXPIRED IMMEDIATELY DURING ENDOSCOPY BECAUSE OF A PERFORATION INTO THE HEART. A PATIENT POST MORTEM WAS PERFORMED, AND AN ESOPHAGEAL FISTULA WAS CONFIRMED. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE DEATH IS THAT IT WAS CAUSED BY THE ESOPHAGEAL FISTULA. PHYSICIANS OPINION REGARDING THE CAUSE OF THE ESOPHAGEAL FISTULA IS UNCLEAR; HOWEVER, THE INITIAL THOUGHTS WAS THAT IT WAS PROCEDURE-RELATED. THE OVERALL TIME FOR ABLATION AND THE LAST ABLATION CYCLE AT THE SITE OF INJURY ARE UNKNOWN. THE SMARTABLATE GENERATOR KIT-WW PARAMETERS INCLUDE POWER CONTROL MODE AT 40 WATTS. THE IRRIGATION WAS SET AT 30ML. THE NOTED TEMPERATURE, IMPEDANCE AND POWER AT THE TIME OF THE PERFORATION ARE UNKNOWN. THERE WERE NO ERROR MESSAGES OBSERVED ON BWI PRODUCT OR EQUIPMENT DURING THE PROCEDURE. NO MODALITY WAS USED TO PREVENT ESOPHAGEAL INJURY. THERE¿S NO INFORMATION REGARDING SPI VALUE OF THE THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER. IT IS UNKNOWN IF THE THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER WAS IN CLOSE PROXIMITY TO ANOTHER CATHETER. THE THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER WAS ZEROED AFTER THE INITIAL WARM-UP PHASE POST CATHETER CONNECTION TO CARTO 3 PIU. THE CARTO 3 SYSTEM DID NOT INDICATE TO RE-ZERO THE CATHETER. THE FORCE VISUALIZATION FEATURES THAT WERE USED INCLUDED: DASHBORD, VECTOR AND VISITAG WITH ABLATION INDEX. VISITAG MODULE WAS USED WITH A STABILITY PARAMETER OF 3 SECONDS, 3MM, 25%. AN ADDITIONAL RESPIRATORY FILTER WAS USED WITH THE VISITAG. THE COLOR OPTIONS THAT WERE USED PROSPECTIVELY WAS ABLATION INDEX 400-500.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624061 SMARTABLATE GENERATOR KIT-WW SIMILAR DEVICE M490007, PMA # P990071/S017 LPB BIOSENSE WEBSTER INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Death| L