BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYHESIVE PATIENT RETURN ELECTRODE

    MDR report key: 1930843 · Received December 16, 2010

    Report

    Report Number
    3005099803-2010-05135
    Event Type
    Injury
    Date Received
    December 16, 2010
    Date of Event
    November 17, 2010
    Report Date
    November 29, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    GEI
    PMA / PMN Number
    K822572
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF SIX DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2010-05130, 3005099803-2010-05131, 3005099803-2010-05132, 3005099803-2010-05133, AND 3005099803-2010-05134 ADDRESS THE OTHER DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RF 3000 RADIOFREQUENCY GENERATOR, LEVEEN NEEDLE ELECTRODE, AND FOUR PATIENT RETURN GROUNDING PADS WERE USED DURING A LIVER RFA (RADIOFREQUENCY ABLATION) PROCEDURE PERFORMED ON (B)(6) 2010. ACCORDING TO THE COMPLAINANT, A 3CM TUMOR WAS ABLATED ACCORDING TO STANDARD PROCEDURE USING THE 4CM ELECTRODE. THE PHYSICIAN PERFORMED FOUR SEPARATE ABLATIONS BY SEGMENTING THE TUMOR INTO FOUR REGIONS TO ENSURE THAT THE ENTIRE TUMOR WAS COVERED. DURING EACH ABLATION, THE IMPEDANCE WAS ALLOWED TO RISE TO MAXIMUM. THE PHYSICIAN EXPRESSED CONCERN THAT NO AIR BUBBLES WERE VISIBLE UNDER ULTRASOUND AS WAS TYPICAL WITH PREVIOUS PROCEDURES WHICH VERIFIED A SUCCESSFUL ABLATION. THE ACCOUNT FURTHER INDICATED THAT A NURSE MONITORED THE GENERATOR ACCORDING TO THE DIRECTIONS FOR USE (DFU) DOCUMENT. AFTER APPROXIMATELY TWO HOURS THE ABLATION WAS COMPLETE. HOWEVER, WHEN THE GROUNDING PADS WERE REMOVED, PATIENT BURNS, WITH A SEVERITY THAT RANGED BETWEEN FIRST AND SECOND DEGREE, WERE OBSERVED UNDER ALL FOUR PADS. NO VISIBLE DAMAGE WAS NOTED TO THE LEVEEN NEEDLE ELECTRODE OR PATIENT RETURN GROUNDING PADS. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR OBSERVATION AND HAD COOL PACKS APPLIED TO THE BURNED AREAS. THE PATIENT HAS SINCE RECOVERED AND BEEN DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLYHESIVE PATIENT RETURN ELECTRODE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI BOSTON SCIENTIFIC - MARLBOROUGH M001262191 154945

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| O