BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEVEEN? COACCESS?

    MDR report key: 4250935 · Received November 14, 2014

    Report

    Report Number
    2134265-2014-06948
    Event Type
    Malfunction
    Date Received
    November 14, 2014
    Date of Event
    October 21, 2014
    Report Date
    October 21, 2014
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    GEI
    PMA / PMN Number
    K012315
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: PROBABLY (B)(6). (B)(4). THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: EXAMINATION OF THE RETURNED COMPLAINT DEVICE REVEALED THAT THE TINES WERE FULLY RETRACTED. A FUNCTIONAL EVALUATION WAS PERFORMED BY EXTENDING THE ARRAY WITH NO RESISTANCE NOTED. THE TINES WERE FOUND TO PROPERLY FORMED AND EVENLY SPACED. A SECOND FUNCTIONAL EVALUATION WAS PERFORMED BY MEASURING THE CONTINUITY AND ELECTRODE WAS ABLE TO CONDUCT CURRENT INDICATING PROPER CONNECTIVITY AT 0.65 OHMS. WHICH MET SPECIFICATION. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE IS NOT CONFIRMED AS THERE WAS NO EVIDENCE OF THE ALLEGED ISSUE OR ANY ANOMALIES WHICH COULD HAVE CONTRIBUTED TO THE REPORTED DIFFICULTY. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MFR:2134265-2014-06986 & 2134265-2014-07353. IT WAS REPORTED INSUFFICIENT ROLL-OFF OCCURRED. THE PATIENT WAS UNDERGOING A LAPAROSCOPIC RADIOFREQUENCY ABLATION (RFA) TREATMENT PROCEDURE OF THEIR LIVER. A 3.5/15/15 LEVEEN CO-ACCESS NEEDLE WAS POSITIONED. AFTER 30 MINUTES OF ABLATION, THERE WAS NO EVIDENCE OF ANY TYPE OF BURN VISIBLE ON THE SCREEN. THE LEVEEN CO-ACCESS WAS REMOVED AND ABLATION WAS THEN PERFORMED WITH A 3.0/15/15 LEVEEN¿ STANDARD NEEDLE. THE LIVER WAS ABLATED SUCCESSFULLY. HOWEVER, ABOUT HALFWAY THROUGH THE ABLATION, APPROXIMATELY 45 MINUTES IN, A BURN WAS NOTED AT THE NEEDLE ACCESS SITE. A 2X2X2 INCH SECTION OF SKIN AND ADIPOSE TISSUE WAS REMOVED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT¿S STATUS IS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED INSUFFICIENT ROLL-OFF OCCURRED. THE PATIENT WAS UNDERGOING A LAPAROSCOPIC RADIOFREQUENCY ABLATION (RFA) TREATMENT PROCEDURE OF THEIR LIVER. A 3.5/15/15 LEVEEN CO-ACCESS NEEDLE WAS POSITIONED. AFTER 30 MINUTES OF ABLATION, THERE WAS NO EVIDENCE OF ANY TYPE OF BURN VISIBLE ON THE SCREEN. THE LEVEEN CO-ACCESS WAS REMOVED AND ABLATION WAS THEN PERFORMED WITH A 3.0/15/15 LEVEEN¿ STANDARD NEEDLE. THE LIVER WAS ABLATED SUCCESSFULLY. HOWEVER, ABOUT HALFWAY THROUGH THE ABLATION, APPROXIMATELY 45 MINUTES IN, A BURN WAS NOTED AT THE NEEDLE ACCESS SITE. A 2X2X2 INCH SECTION OF SKIN AND ADIPOSE TISSUE WAS REMOVED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT¿S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736750 LEVEEN? COACCESS? ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI BOSTON SCIENTIFIC - SPENCER M001262230 16966220

    Patients

    Seq Age Sex Outcome Treatment
    1