BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEVEEN¿ SUPERSLIM¿

    MDR report key: 2852728 · Received November 30, 2012

    Report

    Report Number
    3005099803-2012-05511
    Event Type
    Injury
    Date Received
    November 30, 2012
    Date of Event
    September 26, 2012
    Report Date
    November 2, 2012
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    GEI
    PMA / PMN Number
    K012315
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE DEVICE EXPIRATION AND DEVICE MANUFACTURED DATES ARE UNKNOWN. THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISCARDED AND 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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED: IT WAS REPORTED THAT "IT WAS UNDENIABLE THAT THE PERICARDIUM WAS PERFORATED WITH THE LEVEEN [ELECTRODE]." THE FLUID DRAINED FROM THE PERICARDIUM WAS DESCRIBED AS "HEMOID PERICARDIAL FLUID."

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LEVEEN SUPERSLIM ELECTRODE WAS USED DURING A HEPATIC RADIOFREQUENCY ABLATION (RFA) PROCEDURE PERFORMED ON (B)(6) 2012. ON (B)(6) 2012, A TRANSARTERIAL CHEMOEMBOLIZATION (TACE) PROCEDURE WAS PERFORMED ON THE TARGET LESION, WHICH WAS LOCATED IN LIVER SEGMENTS S8 AND S3. ON (B)(6) 2012, A RADIOFREQUENCY ABLATION WAS PERFORMED. THE PRE-OPERATIVE BLOOD EXAMINATION REVEALED THE PATIENT'S NUMBER OF PLATELETS TO BE 114,000/UL, AND THE PROTHROMBIN RATIO WAS 80.7 PERCENT (THE PATIENT WAS NOT TAKING ANTICOAGULANTS). THE INITIAL PUNCTURE WAS PERFORMED VIA COMPUTED TOMOGRAPHY (CT), AND IT WAS CONFIRMED THAT THE LEVEEN SUPERSLIM ELECTRODE WAS POSITIONED PROPERLY IN LIVER SECTION S3. THIS SECTION WAS ABLATED WITH NO ISSUES, AND THE ELECTRODE WAS REPOSITIONED IN SECTION S8. HOWEVER, AFTER THE ABLATION IN SECTION S8, AN ACCUMULATION OF FLUID IN THE PERICARDIUM WAS NOTED. THE PROCEDURE WAS COMPLETED AND THE PATIENT WAS SENT TO THE CORONARY CARE UNIT FOR OBSERVATION, WHERE A DECREASE IN BLOOD PRESSURE WAS OBSERVED. A PHYSICIAN IN THE CARDIOVASCULAR DISEASE DIVISION CONFIRMED THE PATIENT HAD EXPERIENCED CARDIAC TAMPONADE, AND PERCUTANEOUS PERICARDIAL DRAINAGE WAS SUBSEQUENTLY PERFORMED. IT WAS REPORTED THAT "IT WAS UNDENIABLE THAT THE PERICARDIUM [HAD BEEN] PERFORATED." THE PATIENT WAS THEN TRANSFERRED TO A GENERAL WARD FOR OBSERVATION, AND SHE LEFT THE HOSPITAL ON (B)(6), 2012. THE PATIENT¿S CURRENT CONDITION WAS REPORTED TO BE "GOOD."

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LEVEEN SUPERSLIM ELECTRODE WAS USED DURING A HEPATIC RADIOFREQUENCY ABLATION (RFA) PROCEDURE PERFORMED ON (B)(6) 2012. ON (B)(6) 2012, A TRANSARTERIAL CHEMOEMBOLIZATION (TACE) PROCEDURE WAS PERFORMED ON THE TARGET LESION, WHICH WAS LOCATED IN LIVER SEGMENTS S8 AND S3. ON (B)(6) 2012, A RADIOFREQUENCY ABLATION WAS PERFORMED. THE PRE-OPERATIVE BLOOD EXAMINATION REVEALED THE PATIENT'S NUMBER OF PLATELETS TO BE 114,000/UL, AND THE PROTHROMBIN RATIO WAS 80.7 PERCENT (THE PATIENT WAS NOT TAKING ANTICOAGULANTS). THE INITIAL PUNCTURE WAS PERFORMED VIA COMPUTED TOMOGRAPHY (CT), AND IT WAS CONFIRMED THAT THE LEVEEN SUPERSLIM ELECTRODE WAS POSITIONED PROPERLY IN LIVER SECTION S3. THIS SECTION WAS ABLATED WITH NO ISSUES, AND THE ELECTRODE WAS REPOSITIONED IN SECTION S8. HOWEVER, AFTER THE ABLATION IN SECTION S8, AN ACCUMULATION OF FLUID IN THE PERICARDIUM WAS NOTED. THE PROCEDURE WAS COMPLETED AND THE PATIENT WAS SENT TO THE CORONARY CARE UNIT FOR OBSERVATION, WHERE A DECREASE IN BLOOD PRESSURE WAS OBSERVED. A PHYSICIAN IN THE CARDIOVASCULAR DISEASE DIVISION CONFIRMED THE PATIENT HAD EXPERIENCED CARDIAC TAMPONADE, AND PERCUTANEOUS PERICARDIAL DRAINAGE WAS SUBSEQUENTLY PERFORMED. IT WAS REPORTED THAT "IT WAS UNDENIABLE THAT THE PERICARDIUM [HAD BEEN] PERFORATED." THE PATIENT WAS THEN TRANSFERRED TO A GENERAL WARD FOR OBSERVATION, AND SHE LEFT THE HOSPITAL ON (B)(6) 2012. THE PATIENT'S CURRENT CONDITION WAS REPORTED TO BE "GOOD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEVEEN¿ SUPERSLIM¿ ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI BOSTON SCIENTIFIC - SPENCER M001262280

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention