BEUDAMED
    FDA Adverse Event Death Summary report: N

    COACCES NEEDLE ELECTRODE

    MDR report key: 855592 · Received May 25, 2007

    Report

    Report Number
    6000037-2007-00026
    Event Type
    Death
    Date Received
    May 25, 2007
    Date of Event
    April 30, 2007
    Report Date
    May 3, 2007
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    GEI
    PMA / PMN Number
    K012315
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    D4-USER FACILITY WAS UNABLE TO SUPPLY THE CORRECT LOT NUMBER OF THE DEVICE USED; CONSEQUENTLY, THE EXPIRATION DATE OF THE DEVICE IS UNKNOWN. D11-UNKNOWN/NO INFORMATION AVAILABLE FROM USER FACILITY. USER FACILITY WAS UNABLE TO SUPPLY THE CORRECT LOT NUMBER OF THE DEVICE USED, CONSEQUENTLY, THE MANUFACTURE DATE OF THE DEVICE IS UNKNOWN. THE COMPLAINANT REPORTED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE AND WE ARE UNABLE TO DETERMINE IF THE DEVICE MET SPECIFICATION. A LOT HISTORY SEARCH WAS NOT PERFORMED, AS THE LOT/BATCH NUMBER OF THE DEVICE WAS UNABLE TO BE PROVIDED BY THE COMPLAINANT FACILITY. IN ADDITION, A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT PERFORMED, ALSO DUE TO THE LOT NUMBER NOT BEING PROVIDED. A SHIP HISTORY PERFORMED WHICH FOUND THAT LOT NUMBERS 8951622, 9028653 AND 8969103 WERE THE LAST THREE LOTS SENT TO THIS COSTUMER. A LOT HISTORY SEARCH WAS PERFORMED ON THE LAST THREE LOTS SHIPPED TO THE CUSTOMER. THIS SEARCH FOUND NO OTHER COMPLAINTS AGAINST LOT NUMBERS 9028653 AND 8969103. ONE OTHER COMPLAINT WAS FOUND AGAINST LOT NUMBER 8951622 FOR THE ELECTRODE BEING BENT. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR LOTS 8951622, 9028653 AND 8969103 THIS REVIEW REVEALED NO ANOMALIES. A FAILURE ANALYSIS COULD NOT BE PERFORMED DUE TO THE DEVICE NOT BEING RETURNED FOR EVALUATION. PER THE EVENT DESCRIPTION THERE WAS NO INDICATION THAT THE DEVICE FAILED IN ANY WAY, THE OUTCOME OF THE PATIENT APPEARS TO BE DUE TO COMPLICATIONS FROM THE PROCEDURE, NOT THE DEVICE ITSELF. AT THIS TIME, WE ARE UNABLE TO DETERMINE A RELATIONSHIP BETWEEN THE DEVICE AND THE CAUSE FOR THIS EVENT. IN 2007, RF PROBES PRODUCT FAMILY TRENDING CHART WAS REVIEWED AND THE PRODUCT FAMILY IS NOT AT OR ABOVE THE COMPLAINT ACTION LIMIT (CAL) AND DOES NOT SHOW A NEGATIVE TREND.

    Description of Event or Problem · 1

    THE COMPLAINANT REPORTED THAT A MALE PATIENT, WAS REFERRED TO THE FACILITY FOR A RIGHT LUNG TUMOR RADIOFREQUENCY ABLATION (RFA) PROCEDURE. THE PATIENT HAD PREVIOUSLY UNDERGONE RADIOTHERAPY FOR A TUMOR IN HIS LEFT LUNG, WHICH HAD LEFT IT WITH MINIMAL FUNCTIONALITY. THE TREATMENT TOOK PLACE IN 2007. THE PATIENT WAS FULLY SEDATED AND VENTILATED UNDER ANESTHETIC GUIDANCE. THE PATIENT WAS PLACED IN A PRONE POSITION TO GAIN A BETTER POSITION TO ACCESS THE TUMOR WITH THE COACCESS NEEDLE ELECTRODE. THE PROCEDURE WAS PERFORMED PERCUTANEOUSLY. THE NEEDLE WAS PLACED UNDER CT GUIDANCE AND PLACEMENT WAS CONFIRMED AT VARIOUS STAGES. A 4CM RFA NEEDLE WAS USED. THE ABLATION TREATMENT FOLLOWED THE RFA ALGORITHM FOR >25% PLEURAL CONTACT. THE FIRST ABLATION TIME WAS 29 MINUTES AND 57 SECONDS. THE NEEDLE WAS THEN WITHDRAWN AND A SECOND ABLATION WAS CARRIED OUT, THIS TIME FOR A FURTHER 29 MINUTES. UNDER CT SCANNING A HEMO-PNEUMOTHORAX WAS NOTICED (PER THE COMPLAINANT "A KNOWN COMPLICATION"), AN 8FR CHEST DRAIN WAS INSERTED WITH GOOD RESULT. THE PNEUMOTHORAX WAS SEEN TO ALMOST COMPLETELY RESOLVE. THE NEEDLE TRACK WAS THEN ABLATED TO PREVENT TUMOR SEEDING. THE COMPLAINANT REPORTED THAT THE PROCEDURE WAS SUCCESSFULLY COMPLETED. FOLLOWING THE PROCEDURE THE PATIENT WAS RETURNED TO THE WARD WHERE RECOVERY WAS GOING WELL AND TO PLAN. THE PATIENT WAS PLANNED FOR DISCHARGE FROM HOSPITAL TO HOME ON THE FOLLOWING MONTH. HE FIRST REQUIRED A CHEST X-RAY WHICH WAS PLANNED FOR THAT WEDNESDAY MORNING. UPON ARRIVAL TO THE X-RAY DEPARTMENT, THE PT WAS AWAKE AND TALKING. WHILE WAITING FOR THE X-RAY IN THE WAITING AREA, THE PATIENT STARTED TO SUFFER FROM HEMOPTASIS (COUGHING UP BLOOD), HE THEN SUBSEQUENTLY SUFFERED A CARDIAC ARREST. THE CRASH TEAM WAS CALLED, AND CPR ADMINISTERED. UNFORTUNATELY, THE TEAM WAS UNABLE TO INTUBATE THE PATIENT, DUE TO LARGE AMOUNTS OF BLOOD IN HIS AIRWAY. A CONSULTANT ANESTHETIST WAS CALLED, WHO MANAGED TO INTUBATE THE PATIENT, AND DIAGNOSED A LARGE PNEUMOTHORAX. A LARGE GAUGE CHEST DRAIN WAS INSERTED, WHICH THEN DUMPED LARGE AMOUNTS OF BLOOD. CPR WAS CONTINUED FOLLOWING EUROPEAN RESUSCITATION GUIDELINES. CPR WAS UNSUCCESSFUL AND THE PATIENT WAS PRONOUNCED DEAD. THE PATIENT OUTCOME WAS ATTRIBUTED TO CARDIAC ARREST, DUE TO HEMO-PNEUMOTHORAX. THE PHYSICIAN WAS REPORTED TO SEE THE EVENT AS A COMPLICATION OF LUNG RFA. THE COMPLAINANT INDICATED THAT NO BLAME FOR THE PATIENT OUTCOME HAS BEEN ATTRIBUTED TO THE CO ACCESS NEEDLE ELECTRODE OR TO THE RFA GENERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COACCES NEEDLE ELECTRODE GEI BOSTON SCIENTIFIC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death RADIOFREQUENCY ABLATION GENERATOR| CATALOG NUMBER 26-220| LOT NUMBER/SERIAL NUMBER UNKNOWN