BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PMTA ACCU2I STANDARD APPLICATOR

    MDR report key: 4909647 · Received July 8, 2015

    Report

    Report Number
    1319211-2015-00308
    Event Type
    Injury
    Date Received
    July 8, 2015
    Date of Event
    June 1, 2015
    Report Date
    June 11, 2015
    Manufacturer
    ANGIODYNAMICS, INC.
    Product Code
    NEY
    PMA / PMN Number
    K122762
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED DEFECTIVE DEVICE HAS NOT YET TO BE RETURNED TO THE MANUFACTURER FOR A DEVICE EVALUATION. THE FIRM IS ATTEMPTING TO OBTAIN THE DEVICE. AN INVESTIGATION INTO THE ROOT CAUSE FOR PRODUCT PROBLEM IS CURRENTLY IN PROGRESS. THE RESULTS OF THE DEVICE EVALUATION WILL BE SENT VIA A FOLLOW UP MEDWATCH. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED FOR ANY DEVIATIONS RELATED TO THE REPORTED DEFECT OF THE COMPLAINT. THE REVIEW CONFIRMS THAT THE LOTS MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    RETURNED FOR EVALUATION WAS ONE PMTA ACCU2I INTERMEDIATE APPLICATOR. A VISUAL EXAMINATION OF THE DEVICE NOTED THAT THE TIP OF THE APPLICATOR WAS BROKEN OFF AND FULLY DETACHED. FUNCTIONAL TESTING COULD NOT BE PERFORMED ON THE RETURNED APPLICATOR DUE TO THE CONDITION OF THE DEVICE. THE CUSTOMER'S REPORTED COMPLAINT DESCRIPTION OF THE TIP FRACTION IS CONFIRMED. ALTHOUGH THE EXACT ROOT CAUSE OF THE EVENT IS UNABLE TO BE DETERMINED, IT DOES NOT APPEAR TO BE THE RESULT OF A MANUFACTURING FAILURE. A POSSIBLE CONTRIBUTING FACTOR COULD HAVE BEEN OPERATIONAL CONTEXT; I.E. PROBE PLACEMENT INTO HARD TISSUE OR LATERAL FORCES ON THE APPLICATOR TIP DURING PLACEMENT OR REMOVAL. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED FOR ANY DEVIATIONS RELATED TO THE REPORTED DEFECT OF THE COMPLAINT. REVIEW CONFIRMS THAT THE LOTS MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS. THE INSTRUCTIONS FOR USE, WHICH IS SUPPLIED TO WITH CATALOG NUMBER STATES "ALWAYS ADVANCE THE APPLICATOR INTO THE TARGET TISSUE USING AXIAL FORCES ONLY. AVOID PLACING LATERAL FORCES ON THE APPLICATOR TIP DURING PLACEMENT OR REMOVAL" AND LATERAL FORCES ON THE APPLICATOR TIP SHOULD BE AVOIDED BOTH DURING INSERTION AND REMOVAL. FAILURE TO DO SO COULD RESULT IN DAMAGE TO THE MICROWAVE ARRAY, FAILURE OF THE APPLICATOR AND INJURY TO THE PATIENT." A REVIEW OF THE ANGIODYNAMICS COMPLAINT SYSTEM NOTED NO TRENDS FOR THIS COMPLAINT TYPE AND PRODUCT FAMILY. THIS TYPE OF COMPLAINT WILL CONTINUE TO BE MONITORED FOR TRENDS.

    Description of Event or Problem · 1

    AS REPORTED (B)(6) 2015, A PATIENT OF UNKNOWN AGE AND GENDER PRESENTED FOR AN MICROWAVE PROCEDURE OF THE LIVER. DURING THE PROCEDURE, AFTER A 12 MINUTE ABLATION, THE TREATING PHYSICIAN NOTED THE TIP OF THE APPLICATOR HAD FRACTURED OFF INSIDE OF THE PATIENT. THE TREATING PHYSICIAN DETERMINED NOT TO REMOVE THE FRACTURED PIECE. THE DEVICE WAS SET ASIDE, AND A NEW OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT WAS REPORTED AS STABLE POST PROCEDURE. IT WAS REPORTED THE DISPOSABLE DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442746 PMTA ACCU2I STANDARD APPLICATOR MICROWAVE APPLICATOR NEY ANGIODYNAMICS, INC. 15100355

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention