BEUDAMED
    FDA Adverse Event Death Summary report: N

    STOCKERT 70 RF GENERATOR

    MDR report key: 5681019 · Received May 26, 2016

    Report

    Report Number
    9612355-2016-00031
    Event Type
    Death
    Date Received
    May 26, 2016
    Date of Event
    April 28, 2016
    Report Date
    April 28, 2016
    Manufacturer
    STOCKERT GMBH
    Product Code
    LPB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. CONCOMITANT PRODUCT: CARTO 3 SYSTEM, MODEL #: M-4800-01, SERIAL #: (B)(4). (B)(4).

    Additional Manufacturer Narrative · 1

    DUE TO THE AUGUST 2015 FDA MAINTENANCE WHERE THE 3500A CODES WERE UPDATED, THE 3500A CODES (EVALUATION CODES) WILL BE ADDED UNTIL THE BIOSENSE WEBSTER SYSTEM IS ALSO UPDATED. MANUFACTURER'S REF. NO: (B)(4). IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE FOR ATRIAL FIBRILLATION WITH A SMARTTOUCH BIDIRECTIONAL CATHETER AND THE STOCKERT 70 RF GENERATOR AND SUFFERED AN ATRIO-ESOPHAGEAL FISTULA THAT RESULTED IN DEATH. IT WAS NOTED THAT A NURSE RELAYED THE PROCEDURE INFORMATION TO A BIOSENSE WEBSTER FIELD REPRESENTATIVE WHO WAS NOT PRESENT AT THE PROCEDURE. THE NURSE INDICATED THAT THE PATIENT DIED AS A RESULT OF AN ESOPHAGEAL FISTULA SECONDARY TO RADIOFREQUENCY ABLATION. THE BIOSENSE WEBSTER FIELD REPRESENTATIVE NOTED THAT THE PHYSICIAN GENERALLY USES A SMARTTOUCH GENERATION 2 F/J CURVE CATHETER WITH AN ESOPHAGEAL TEMPERATURE PROBE TO HELP PREVENT ESOPHAGEAL INJURY. THERE IS NO INFORMATION REGARDING MEDICAL OR SURGICAL INTERVENTION. THERE IS NO INFORMATION REGARDING EXTENDED HOSPITALIZATION. THERE WERE NO ISSUES WITH THE CATHETER. PHYSICIAN DID NOT PROVIDE CAUSALITY OPINION. THE DEVICE WAS EVALUATED AND NO ERROR WAS FOUND. THE DEVICE IS WITHIN SPECIFICATION. SERVICE WAS DECLINED. THE DEVICE HISTORY RECORD (DHR) 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 PATIENT UNDERWENT AN ABLATION PROCEDURE FOR ATRIAL FIBRILLATION WITH A SMARTTOUCH BIDIRECTIONAL CATHETER AND THE STOCKERT 70 RF GENERATOR AND SUFFERED AN ATRIO-ESOPHAGEAL FISTULA THAT RESULTED IN DEATH. IT WAS NOTED THAT A NURSE RELAYED THE PROCEDURE INFORMATION TO A BIOSENSE WEBSTER FIELD REPRESENTATIVE WHO WAS NOT PRESENT AT THE PROCEDURE. THE NURSE INDICATED THAT THE PATIENT DIED AS A RESULT OF AN ESOPHAGEAL FISTULA SECONDARY TO RADIOFREQUENCY ABLATION. THE BIOSENSE WEBSTER FIELD REPRESENTATIVE NOTED THAT THE PHYSICIAN GENERALLY USES A SMARTTOUCH GENERATION 2 F/J CURVE CATHETER WITH AN ESOPHAGEAL TEMPERATURE PROBE TO HELP PREVENT ESOPHAGEAL INJURY. THERE IS NO INFORMATION REGARDING MEDICAL OR SURGICAL INTERVENTION. THERE IS NO INFORMATION REGARDING EXTENDED HOSPITALIZATION. THERE WERE NO ISSUES WITH THE CATHETER. PHYSICIAN DID NOT PROVIDE CAUSALITY OPINION. ADDITIONAL CLARIFICATION WAS REQUESTED ON THIS EVENT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. SINCE THIS ADVERSE EVENT RESULTED IN THE PATIENT'S DEATH, IT IS MDR REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338261 STOCKERT 70 RF GENERATOR SIMILAR DEVICE S7001, PMA # P990071 LPB STOCKERT GMBH M-5463-02

    Patients

    Seq Age Sex Outcome Treatment
    1 Death