BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STOCKERT EP-SHUTTLE RADIO FREQUENCY GENERATOR

    MDR report key: 3102508 · Received May 9, 2013

    Report

    Report Number
    9612355-2013-00022
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 19, 2013
    Report Date
    April 19, 2013
    Manufacturer
    STOCKERT GMBH
    Product Code
    DRF
    PMA / PMN Number
    P990071
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT DURING A PAROXYSMAL ATRIAL FIBRILLATION (AFIB) PROCEDURE THERE WAS NO IMPEDANCE ON THE EP - SHUTTLE RF GENERATOR SYSTEM - 100W OR IT WAS TOO HIGH. FULL TROUBLESHOOTING WAS PERFORMED. THE INDIFFERENCE CABLE, INDIFFERENCE PATCH, THE CONNECTION CABLE BETWEEN THE CARTO SYSTEM AND THE EP-SHUTTLE RF GENERATOR SYSTEM, RF ADAPTOR CABLE, SMARTOUCH CABLE AND THE CATHETER WERE ALL REPLACED BUT ALL THIS TROUBLESHOOTING DID NOT RESOLVE THE ISSUE. THE PROCEDURE WAS CANCELLED. UPON REQUEST, THE BWI FIELD REPRESENTATIVE PROVIDED ADDITIONAL INFORMATION ON THE EVENT. THE IMPEDANCE DISPLAYED WAS REFLECTING AS --- OR 000. THE PHYSICIAN NOTICED THIS ISSUE WHEN HE WANTED TO START TO ABLATE. THERE WAS NO ABLATION BEING DELIVERED WITH THIS IMPEDANCE ISSUE. THE IMPEDANCE CUT-OFF SETTING WAS THE NORMAL ADVISED SETTINGS. THE PATIENT WAS ALREADY ON THE TABLE AND HAD A TRANSSEPTAL PUNCTURE. THE PROCEDURE WAS BEING PERFORMED IN THE LEFT ATRIUM AS IT WAS A PULMONARY VEIN ISOLATION. THE PROCEDURE HAD TO BE CANCELLED AND RESCHEDULED. THE PROCEDURE WAS ONLY CANCELLED BECAUSE OF THE ISSUE WITH THE EP-SHUTTLE RF GENERATOR SYSTEM - 100WS. THE PATIENT WAS UNDER LOCAL ANESTHESIA. SINCE THE PATIENT WAS RESCHEDULED, SHE HAD TO BE HOSPITALIZED AGAIN. THERE WAS NO PATIENT INJURY REPORTED IN THIS CASE BUT THE PHYSICIAN THINKS CANCELLING THE PROCEDURE CAUSED A POTENTIAL RISK TO THE PATIENT. PER THE EVENT DESCRIPTION, THE UNIT WAS SERVICED AND NO ERRORS WERE FOUND. FUNCTIONAL AND SAFETY TEST WERE PERFORMED AS WELL AS PREVENTATIVE MAINTENANCE. THE DEVICE HISTORY RECORD (DHR) FOR THE STOCKERT GENERATOR SERIAL NUMBER (B)(6) SHOWS THAT NO MANUFACTURING OR TEST FAILS WERE NOTED DURING THE MANUFACTURING CYCLE RELATED TO FUNCTIONALITY OF THE DEVICE. THE DEVICE MET ALL REQUIREMENTS PRIOR TO DISTRIBUTION.

    Additional Manufacturer Narrative · 1

    INVESTIGATION STILL IN PROGRESS. A SUPPLEMENTAL REPORT OR DEVICE EVALUATION WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PAROXYSMAL ATRIAL FIBRILLATION (AFIB) PROCEDURE THERE WAS NO IMPEDANCE ON THE EP - SHUTTLE RF GENERATOR SYSTEM - 100W OR IT WAS TOO HIGH. FULL TROUBLESHOOTING WAS PERFORMED. THE INDIFFERENCE CABLE, INDIFFERENCE PATCH, THE CONNECTION CABLE BETWEEN THE CARTO SYSTEM AND THE EP-SHUTTLE RF GENERATOR SYSTEM, RF ADAPTOR CABLE, SMARTOUCH CABLE AND THE CATHETER WERE ALL REPLACED BUT ALL THIS TROUBLESHOOTING DID NOT RESOLVE THE ISSUE. THE PROCEDURE WAS CANCELLED.UPON REQUEST, THE BWI FIELD REPRESENTATIVE PROVIDED ADDITIONAL INFORMATION ON THE EVENT. THE IMPEDANCE DISPLAYED WAS REFLECTING AS --- OR 000. THE PHYSICIAN NOTICED THIS ISSUE WHEN HE WANTED TO START TO ABLATE. THERE WAS NO ABLATION BEING DELIVERED WITH THIS IMPEDANCE ISSUE. THE IMPEDANCE CUT-OFF SETTING WAS THE NORMAL ADVISED SETTINGS. THE PATIENT WAS ALREADY ON THE TABLE AND HAD A TRANSSEPTAL PUNCTURE. THE PROCEDURE WAS BEING PERFORMED IN THE LEFT ATRIUM AS IT WAS A PULMONARY VEIN ISOLATION. THE PROCEDURE HAD TO BE CANCELLED AND RESCHEDULED. THE PROCEDURE WAS ONLY CANCELLED BECAUSE OF THE ISSUE WITH THE EP-SHUTTLE RF GENERATOR SYSTEM - 100WS. THE PATIENT WAS UNDER LOCAL ANESTHESIA. SINCE THE PATIENT WAS RESCHEDULED, SHE HAD TO BE HOSPITALIZED AGAIN. THERE WAS NO PATIENT INJURY REPORTED IN THIS CASE BUT THE PHYSICIAN THINKS CANCELLING THE PROCEDURE CAUSED A POTENTIAL RISK TO THE PATIENT.SINCE THE CASE WAS CANCELLED AFTER TRANSSEPTAL PUNCTURE AND THE PATIENT HAD TO BE RESCHEDULED AND HOSPITALIZED AGAIN, THIS IS INDICATIVE OF A REPORTABLE EVENT, THUS MARKING (B)(6) 2013 AS THE ALERT DATE FOR THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204187 STOCKERT EP-SHUTTLE RADIO FREQUENCY GENERATOR RADIOFREQUENCY GENERATOR AND ACCESSORIES/ACCESSORY CABLE DRF STOCKERT GMBH 39D-76X

    Patients

    Seq Age Sex Outcome Treatment
    1