BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASPIREASSIST A-TUBE

    MDR report key: 7455224 · Received April 24, 2018

    Report

    Report Number
    3009595931-2018-00001
    Event Type
    Malfunction
    Date Received
    April 24, 2018
    Date of Event
    April 6, 2018
    Report Date
    April 23, 2018
    Manufacturer
    ASPIRE BARIATRICS, INC.
    Product Code
    OYF
    PMA / PMN Number
    P150024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE A-TUBE WAS FOUND IN 2 PIECES IN THE STOMACH. THE STOMA PORTION AND BUMPER WERE SECURELY IN PLACE. GASTRIC SECTION OF THE TUBE WAS NEAR THE BUMPER AND LYING ALONG THE STOMACH WALL WITH THE TOP PORTION LOCATED IN THE FUNDUS, WHICH IS NORMAL PLACEMENT FOR THE A-TUBE. THE TUBE WAS SEPARATED AT THE FIRST ASPIRATION HOLE NEAR THE BUMPER. BOTH SECTIONS OF THE TUBE WERE EASILY REMOVED AND THE PATIENT TOLERATED THE PROCEDURE WELL. VISUAL EXAMINATION OF A-TUBE FOUND DISCOLORATION ON EXPOSED SURFACES AT THE POINT OF SEPARATION INDICATING THAT THE TUBE SEPARATION OCCURRED OVER SOME PERIOD OF TIME. TESTING OF EXPLANTED A-TUBES INDICATES MATERIAL DEGRADATION WHICH MAY BECOME SIGNIFICANT AFTER 3 YEARS WITH REGARDS TO TENSILE STRENGTH AND ELONGATION AT BREAK WHICH MAY INCREASE THE PROBABILITY OF SEPARATION PRIOR TO OR DURING A-TUBE REMOVAL. ASPIRE WILL CONSIDER INCLUDING A RECOMMENDATION FOR REMOVAL/REPLACEMENT AT ABOUT 3 YEARS TO FURTHER REDUCE THE PROBABILITY OF OCCURRENCE.

    Description of Event or Problem · 1

    DURING PLANNED EXPLANT, ENDOSCOPY REVEALED A-TUBE WAS "SEVERED" FROM INTERNAL BUMPER. THE STOMA PORTION AND BUMPER WERE SECURELY IN PLACE. GASTRIC SECTION OF THE TUBE WAS NEAR THE BUMPER AND LYING ALONG THE STOMACH WALL WITH THE TOP PORTION LOCATED IN THE FUNDUS, WHICH IS NORMAL PLACEMENT FOR THE A-TUBE. THE TUBE WAS SEPARATED AT THE FIRST ASPIRATION HOLE NEAR THE BUMPER. BOTH SECTIONS OF THE TUBE WERE EASILY REMOVED AND THE PATIENT TOLERATED THE PROCEDURE WELL. THIS WAS A DEVICE FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296968 ASPIREASSIST A-TUBE GASTROSTOMY TUBE OYF ASPIRE BARIATRICS, INC. NOT APPLICABLE F100224

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention