BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STOCKERT 70 RF GENERATOR

    MDR report key: 3227358 · Received July 15, 2013

    Report

    Report Number
    9612355-2013-00034
    Event Type
    Injury
    Date Received
    July 15, 2013
    Date of Event
    June 19, 2013
    Report Date
    June 19, 2013
    Manufacturer
    STOCKERT GMBH
    Product Code
    DRF
    PMA / PMN Number
    P990071
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION STILL IN PROGRESS. A SUPPLEMENTAL REPORT OR DEVICE EVALUATION WILL BE SUBMITTED. CONCOMITANT PRODUCTS: COOLFLOW PUMP; MODEL: M-5491-02; SERIAL #: (B)(4). LASSO CATHETER: MODEL: D-1220-39-S; LOT #: 15823297L. ACUNAV CATHETER - DISTRIBUTED PRODUCT: MODEL #: M-5723-01; LOT #: OEM_M-5723-01. BIOSENSE WEBSTER MANUFACTURER'S REF. (B)(4) ARE RELATED TO THE SAME INCIDENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT DURING AN ATRIAL FIBRILLATION (AFIB) PROCEDURE, A PERICARDIAL EFFUSION WAS NOTICED AS THE PATIENT'S BLOOD PRESSURE DROPPED. THE PERICARDIAL EFFUSION WAS CONFIRMED BY A SURFACE ECHOCARDIOGRAM. A PERICARDIOCENTESIS WAS PERFORMED AND THE PATIENT WAS REPORTED TO BE IN THE ICU IN STABLE CONDITION. PER THE BWI FIELD REPRESENTATIVE, THE NURSE STATED AT THE BEGINNING OF THE CASE, ABERRANT MESSAGES WERE BEING RELAYED FROM THE STOCKERT 70 SYSTEM TO THE PRUKA RECORDING SYSTEM. ONE OF THE MESSAGES DISPLAYED THAT THE POWER SETTINGS WERE 74 WATTS ON THE PRUKA RECORDING SYSTEM. THE NURSE COULD NOT CONFIRM IF THIS POWER SETTING WAS THE SAME ON THE STOCKERT 70 SYSTEM AS IT WAS ON THE PRUKA RECORDING SYSTEM. THE BWI FIELD REPRESENTATIVE REPORTED THAT THE SERIAL CABLE FROM THE STOCKERT 70 SYSTEM TO THE GLOBAL PORT WAS REPLACED WITH NO RESOLUTION AND THAT WHEN THE GLOBAL PORT WAS REPLACED, THE ISSUE MENTIONED ABOVE RESOLVED. UPON REQUEST, ADDITIONAL INFORMATION WAS PROVIDED ON THE EVENT BY THE BWI FIELD SERVICE ENGINEER. THE EVENT OCCURRED DURING THE ABLATION PHASE. THE PHYSICIAN¿S OPINION REGARDING THE CAUSALITY OF THE PERFORATION/TAMPONADE WAS THE STEAM POP. THERE WERE NO OTHER FACTOR THAT MIGHT HAVE CONTRIBUTED TO THE CARDIAC PERFORATION/TAMPONADE EVENT. THE PHYSICIAN DID NOT EXPERIENCE ANY DIFFICULTY IN MANIPULATING THE CATHETER. IT WAS UNKNOWN HOW MANY ABLATION APPLICATIONS WERE DELIVERED TO THE PATIENT BEFORE THE EVENT. THE RF GENERATOR SET TO ¿POWER-CONTROL¿ MODE. THE POWER SETTING AND TEMPERATURE CUT OFF SETTING WERE UNKNOWN. THE FLOW SETTING WAS SET TO 30ML/MIN. THE ACT MAINTAINED DURING THE PROCEDURE WAS >350. THE SJ SHEATH WAS USED. THE UNIT WAS RETURNED FOR SERVICE AND IT WAS FOUND THAT THE BACK FRAME AND CARD HOLDER NIS WERE BROKEN AND THE ISSUE WAS RESOLVED BY REPLACING THEM, IN ADDITION IT WAS FOUND THAT THERE WAS A PIN STICK IN THE ECG PLUG AND IT WAS RESOLVED BY REPLACING THE ECG PLUG, HOWEVER THE ROOT CAUSE OF THE REPORTED CONDITION REMAINS UNKNOWN. FUNCTIONAL AND SAFETY TEST WAS PERFORMED AS WELL AS A PREVENTATIVE MAINTENANCE. THE DEVICE HISTORY RECORD (DHR) FOR THE STOCKERT GENERATOR SERIAL NUMBER (B)(4) 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ATRIAL FIBRILLATION (AFIB) PROCEDURE, A PERICARDIAL EFFUSION WAS NOTICED AS THE PATIENT'S BLOOD PRESSURE DROPPED. THE PERICARDIAL EFFUSION WAS CONFIRMED BY A SURFACE ECHOCARDIOGRAM. A PERICARDIOCENTESIS WAS PERFORMED AND THE PATIENT WAS REPORTED TO BE IN THE ICU IN STABLE CONDITION. PER THE BWI FIELD REPRESENTATIVE, THE NURSE STATED AT THE BEGINNING OF THE CASE, ABERRANT MESSAGES WERE BEING RELAYED FROM THE STOCKERT 70 SYSTEM TO THE PRUKA RECORDING SYSTEM. ONE OF THE MESSAGES DISPLAYED THAT THE POWER SETTINGS WERE 74 WATTS ON THE PRUKA RECORDING SYSTEM. THE NURSE COULD NOT CONFIRM IF THIS POWER SETTING WAS THE SAME ON THE STOCKERT 70 SYSTEM AS IT WAS ON THE PRUKA RECORDING SYSTEM. THE BWI FIELD REPRESENTATIVE REPORTED THAT THE SERIAL CABLE FROM THE STOCKERT 70 SYSTEM TO THE GLOBAL PORT WAS REPLACED WITH NO RESOLUTION AND THAT WHEN THE GLOBAL PORT WAS REPLACED, THE ISSUE MENTIONED ABOVE RESOLVED. UPON REQUEST, ADDITIONAL INFORMATION WAS PROVIDED ON THE EVENT BY THE BWI FIELD SERVICE ENGINEER. THE EVENT OCCURRED DURING THE ABLATION PHASE. THE PHYSICIAN¿S OPINION REGARDING THE CAUSALITY OF THE PERFORATION/TAMPONADE WAS THE STEAM POP. THERE WERE NO OTHER FACTOR THAT MIGHT HAVE CONTRIBUTED TO THE CARDIAC PERFORATION/TAMPONADE EVENT. THE PHYSICIAN DID NOT EXPERIENCE ANY DIFFICULTY IN MANIPULATING THE CATHETER. IT WAS UNKNOWN HOW MANY ABLATION APPLICATIONS WERE DELIVERED TO THE PATIENT BEFORE THE EVENT. THE RF GENERATOR SET TO ¿POWER-CONTROL¿ MODE. THE POWER SETTING AND TEMPERATURE CUT OFF SETTING WERE UNKNOWN. THE FLOW SETTING WAS SET TO 30ML/MIN. THE ACT MAINTAINED DURING THE PROCEDURE WAS >350. THE SJ SHEATH WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327243 STOCKERT 70 RF GENERATOR RADIOFREQUENCY GENERATOR AND ACCESSORIES/ACCESSORY CABLE DRF STOCKERT GMBH M-5463-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R