BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM

    MDR report key: 6535501 · Received May 1, 2017

    Report

    Report Number
    3005594788-2017-00001
    Event Type
    Malfunction
    Date Received
    May 1, 2017
    Date of Event
    September 4, 2014
    Report Date
    April 27, 2017
    Manufacturer
    XOFT, A SUBSIDARY OF ICAD, INC.
    Product Code
    IYC
    PMA / PMN Number
    K090914
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE FAILURE ANALYSIS WAS NOT PERFORMED. THE HOSPITAL FACILITY HAD DISCARDED THE DEVICE. USER ERROR APPEARS TO BE AT FAULT. ACCORDING TO THE REPORTING FACILITY, THE PHYSICIAN HAD INADVERTENTLY PUNCTURED THE BALLOON WITH A SURGICAL INSTRUMENT WHILE THE DEVICE WAS IMPLANTED IN THE PATIENT. NO ACTIVE THERAPY (OR RADIATION) WAS BEING APPLIED AT THE TIME. THE DEVICE WAS EXTRACTED AND REPLACED WITH A NEW DEVICE AND THE PATIENT'S PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT. NO PATIENT INJURY WAS SUSTAINED. A MANUFACTURING LOT HISTORY SEARCH OF THE DEVICE FOUND NO RELATED ANOMALIES. FURTHER, THE DEVICE IFU (INSTRUCTIONS FOR USE) CONTAINS THE FOLLOWING PRECAUTIONARY STATEMENTS IN RELATION TO USING SURGICAL INSTRUMENTS NEAR THE VICINITY OF THE BALLOON APPLICATOR: "EXERCISE CAUTION WHEN HANDLING THE APPLICATOR BALLOON AS WELL AS THE APPLICATOR SHAFT BOTH PRIOR TO AND DURING IMPLANTATION. SILICONE IS SUSCEPTIBLE TO DAMAGE BY SHARP INSTRUMENTS, FORCEPS, SURGICAL CLIPS AND EXCESSIVE PUSHING AND PULLING." "EXERCISE EXTREME CAUTION WHEN USING THE APPLICATOR IN CONJUNCTION WITH SURGICAL MARKING CLIPS TO AVOID PUNCTURE OF THE DEVICE. SURGICAL CLIPS WHICH PROTRUDE INTO THE TREATMENT AREA MAY INCREASE THE RISK OF DAMAGE TO THE BALLOON WHEN IT IS INSERTED AND INFLATED." THE INDICATED INCIDENT HAD OCCURRED ON (B)(6) 2014 AS PART OF THE DEVICE CLINICAL STUDY, BUT WAS REPORTED TO XOFT QUALITY ASSURANCE ON (B)(6) 2017. THE LATE REPORTING OF THIS INCIDENT WAS DUE TO A COMMUNICATION FAULT OCCURRING AT THE CLINICAL SITE. CORRECTIVE ACTION HAS SINCE BEEN IMPLEMENTED AND THE REQUIRED PERSONNEL HAVE BEEN RETRAINED.

    Description of Event or Problem · 1

    THE XOFT 4-5 CM BALLOON APPLICATOR WAS INADVERTENTLY PUNCTURED BY THE PHYSICIAN WHILE THE DEVICE WAS IMPLANTED IN THE PATIENT UNDERGOING INTRAOPERATIVE RADIATION THERAPY (IORT). NO RADIATION THERAPY WAS BEING APPLIED. THE DEVICE WAS REMOVED FROM THE PATIENT AND REPLACED WITH A NEW DEVICE. NO PATIENT INJURY WAS SUSTAINED AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT. XOFT INTERNAL COMPLAINT REFERENCE #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316166 AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM BALLOON APPLICATOR, SIZE 4-5 CM IYC XOFT, A SUBSIDARY OF ICAD, INC. 720331 820985

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other