BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTABLATE¿ SYSTEM RF GENERATOR

    MDR report key: 5318296 · Received December 22, 2015

    Report

    Report Number
    9612355-2015-00073
    Event Type
    Injury
    Date Received
    December 22, 2015
    Date of Event
    October 27, 2015
    Report Date
    November 26, 2015
    Manufacturer
    STOCKERT GMBH
    Product Code
    LPB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. CONCOMITANT MEDICAL PRODUCTS: CARTO 3 SYSTEM (MODEL# M-4800-01 SERIAL# (B)(4)); SMARTABLATE PUMP (MODEL# M-4900-109 SERIAL# (B)(4)); LASSO NAV ECO 2515 (MODEL# D-1343-01-S LOT# UNKNOWN); CARTO 3 PATCHES (MODEL# UNKNOWN LOT# UNKNOWN); ST JUDE MEDICAL AGILIS SM CURVE (MODEL# UNKNOWN LOT # UNKNOWN). THE ¿SUSPECTED MEDICAL DEVICE¿ REPORTED IN THIS REPORT IS NOT MARKETED IN USA OR APPROVED BY THE FDA. HOWEVER, IT IS BEING REPORTED AS BIOSENSE WEBSTER CONSIDERS THIS AS A SIMILAR DEVICE TO SMARTABLATE¿ SYSTEM RF GENERATOR APPROVED UNDER P990071/S017. (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON THE PATIENT. ON (B)(6) 2016, INFORMATION WAS RECEIVED THAT UNFORTUNATELY THE PATIENT SUFFERED A FURTHER SET BACK AND COLLAPSED IN THE WARD. A CT SCAN SHOWED LARGE AIR EMBOLI TO BOTH THE CORONARY ARTERIES AND THE BRAIN, HER PATCHED FISTULA HAD REOPENED (FOR THE SECOND TIME). THE PATIENT WAS TAKEN TO THE THEATRE AND WHILE THE FISTULA ON HER LEFT ATRIUM WAS RE-STITCHED, HER ESOPHAGUS WAS TOO BADLY DAMAGED AND THE SURGEONS OPTED TO REMOVE IT DURING SOME VERY COMPLEX SURGERY. THE PROGNOSIS WAS EXTREMELY POOR AND THE PHYSICIAN EXPECTED THE PATIENT TO PASS AWAY WITHIN THE NEXT 24 HOURS. THE PHYSICIAN IS CONFIDENT THAT VISITAG IS NOT TO BLAME FOR THE ADVERSE EVENT. ON (B)(6) 2016 ADDITIONAL PATIENT STATUS UPDATE WAS RECEIVED THAT THE PASSED AWAY LATE EVENING (B)(6) 2016. DUE TO THE AUGUST 2015 FDA MAINTENANCE WHERE THE 3500A CODES WERE UPDATED, THE 3500A CODES WILL BE ADDED TO UNTIL THE BIOSENSE WEBSTER SYSTEM IS ALSO UPDATED. THEREFORE THE FOLLOWING CODES APPLY: (B)(4). IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT AN ABLATION PROCEDURE FOR PAROXYSMAL ATRIAL FIBRILLATION USING A SMARTABLATE¿ SYSTEM RF GENERATOR AND A THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER AND SUFFERED AN ATRIO-ESOPHAGEAL FISTULA REQUIRING SURGICAL INTERVENTION, CEREBROVASCULAR ACCIDENT, AND PULMONARY EMBOLISM. AN UPDATE WAS LATER RECEIVED THAT THE PATIENT PASSED AWAY. REPAIR FOLLOW-UP WAS PERFORMED AND SERVICE WAS DECLINED. THE COMPLAINT WAS UNABLE TO BE CONFIRMED. THE DEVICE HISTORY RECORD REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT AN ABLATION PROCEDURE FOR PAROXYSMAL ATRIAL FIBRILLATION USING A SMARTABLATE SYSTEM RF GENERATOR AND A THERMOCOOL SMARTTOUCH UNI-DIRECTIONAL NAVIGATION CATHETER AND SUFFERED AN ATRIO-ESOPHAGEAL FISTULA REQUIRING SURGICAL INTERVENTION, CEREBROVASCULAR ACCIDENT, AND PULMONARY EMBOLISM. THE PROCEDURE WAS COMPLETED WITHOUT ANY OBSERVED COMPLICATIONS. THE PATIENT WAS ENROLLED AS PART OF AN ONGOING MULTICENTER STUDY CONCERNING GANGLIONIC PLEXI ABLATION. THERE WERE NO ACUTE COMPLICATIONS AND THE PATIENT WAS DISCHARGED. THE PATIENT DID NOT INITIALLY REQUIRE EXTENDED HOSPITALIZATION. OVERALL ABLATION TIME AT THE SITE OF INJURY WAS 220 SECONDS. THERE WERE NO ERROR MESSAGES ON ANY BIOSENSE WEBSTER EQUIPMENT DURING THE PROCEDURE. THE PATIENT HAD FELT UNWELL SINCE THE ABLATION BUT DID NOT COMPLAIN OF ANYTHING SPECIFIC. FOUR WEEKS LATER, THE PATIENT PRESENTED TO THE HOSPITAL, AFTER HAVING COLLAPSED AT HOME, WITH CHEST PAIN AND FEVER. THE PATIENT WAS ADMITTED TO THE HOSPITAL. CONTRAST COMPUTED TOMOGRAPHY (CT) WAS DONE WHICH DEMONSTRATED A CONNECTION BETWEEN THE ESOPHAGUS AND LEFT ATRIUM AND REVEALED AN ATRIO-ESOPHAGEAL FISTULA WITH A 3-4MM BURN ON THE POSTERIOR-INFERIOR ASPECT OF THE RIGHT LOWER PULMONARY VEIN. CHEST X-RAY REVEALED AIR IN THE PERICARDIUM. DAMAGE WAS MODERATE TO SEVERE AND LATER RESULTED IN AN AIR EMBOLISM, CAUSING POSSIBLE EMBOLIC STROKE EVENT AND RESIDUAL LEFT ARM WEAKNESS. A RIGHT LATERAL THORACOTOMY WAS PERFORMED AND A PATCH PLACED OVER THE DAMAGED LEFT ATRIAL POSTERIOR WALL. AT THE SAME TIME, THE ESOPHAGUS WAS SUTURED TO REPAIR THE DAMAGE. CHEST DRAINS WERE LEFT IN SITU AND THE PATIENT WAS READMITTED FOR AN EXTENDED STAY OF APPROXIMATELY 1-2 WEEKS. AT THE TIME OF COMPLAINT REPORT, THE PATIENT WAS EXTUBATED AND AWAKE. THE PHYSICIAN'S OPINION REGARDING THE CAUSE OF THIS ADVERSE EVENT IS THAT IT WAS PROCEDURE-RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    843201 SMARTABLATE¿ SYSTEM RF GENERATOR SIMILAR DEVICE M490007, PMA # P990071/S017 LPB STOCKERT GMBH M-4900-107

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| L| R