BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASPIREASSIST A-TUBE

    MDR report key: 9554017 · Received January 6, 2020

    Report

    Report Number
    3009595931-2020-00001
    Event Type
    Malfunction
    Date Received
    January 6, 2020
    Date of Event
    December 7, 2019
    Report Date
    January 6, 2020
    Manufacturer
    ASPIRE BARIATRICS, INC
    Product Code
    OYF
    UDI-DI
    10857808005471
    PMA / PMN Number
    P150024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORT INDICATED THAT THE SKIN PORT HAD SEPARATED FROM THE A-TUBE. SUBSEQUENT EMAIL DESCRIBED THE A-TUBE AS SEPARATED AT THE BUMPER. THERE IS NO INFORMATION TO SUGGEST THAT THE A-TUBE WHICH HAD BEEN IMPLANTED FOR 20 MONTHS HAD ANY SIGNS OF MATERIAL DEGRADATION. THE SKIN PORT ATTACHMENT TO THE A-TUBE AND THE A-TUBE OVERMOLD ARE BOTH DESIGNED AND TESTED TO ENSURE THAT NORMAL FORCES WHICH MIGHT BE APPLIED TO THE DEVICE DO NOT RESULT IN SEPARATION WITH AN APPROPRIATE SAFETY MARGIN. WITHOUT HAVING THE DEVICE TO EVALUATE, IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THIS EVENT. THE PATIENT UNDERWENT ENDOSCOPY TO REMOVE THE DEVICE FROM THE STOMACH. THERE WERE NO ISSUES WITH REMOVAL OF THE TUBE AND THE PROCEDURE WAS WELL TOLERATED.

    Description of Event or Problem · 1

    PATIENT IS (B)(6) FEMALE WITH A HISTORY OF OBESITY UNDERGOING ASPIRE ASSIST THERAPY, A-TUBE PLACEMENT IN (B)(6) OF 2018. RN REPORTED BEING CONTACTED BY A PATIENT WHO STATED THAT THE SKIN PORT HAD COME OFF AND THE A-TUBE HAD RETRACTED INTO THE STOMACH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17191 ASPIREASSIST A-TUBE GASTROSTOMY TUBE OYF ASPIRE BARIATRICS, INC NOT APPLICABLE F100913 10857808005471

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention