BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASPIREASSIST A-TUBE

    MDR report key: 6805143 · Received August 18, 2017

    Report

    Report Number
    3009595931-2017-00001
    Event Type
    Malfunction
    Date Received
    August 18, 2017
    Date of Event
    January 21, 2017
    Report Date
    March 10, 2017
    Manufacturer
    ASPIRE BARIATRICS, INC.
    Product Code
    OYF
    PMA / PMN Number
    P150024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE HAVE BEEN A SIGNIFICANT NUMBER OF TUBE REPLACEMENTS OR REMOVALS AND THIS IS THE FIRST SUCH EVENT TO BE REPORTED. MATERIAL SEPARATION HAS BEEN ANTICIPATED IN THE A-TUBE RISK ASSESSMENT AND MITIGATED AS FAR AS POSSIBLE BY DESIGN AND TESTING OF THE A-TUBE, AND ASSESSMENT OF THE RISKS ASSOCIATED WITH REMOVAL OF SEPARATED PIECES OF THE A-TUBE BY ENDOSCOPIC MEANS. WHAT HAS BEEN LEARNED AS A RESULT OF THIS EVENT IS THAT PLACEMENT OF THE SNARE MAY BE IMPORTANT PARTICULARLY IN OLDER IMPLANTS. AS A RESULT THE INSTRUCTIONS FOR A-TUBE REMOVAL ARE BEING REVISED TO SPECIFY PLACEMENT OF THE SNARE AS AN ADDITIONAL MEANS OF RISK REDUCTION. THE CLINICIANS ARE NOW REMINDED NOT TO ATTACH THE SNARE AT THE ASPIRATION HOLES BUT RATHER AT THE FULL CIRCUMFERENCE OF THE A-TUBE FOR MORE SECURE PURCHASE DURING REMOVAL.

    Description of Event or Problem · 1

    DURING THE PROCEDURE WHERE THE A-TUBE WAS REMOVED, THE A-TUBE SPLIT INTO 2 SECTIONS IN ESOPHAGUS. AFTER REMOVAL OF THE SMALL PIECE THE GASTROSCOPE WAS USED AGAIN TO REMOVE THE SECOND PART. NO PROBLEMS REPORTED FOR THE PATIENT. AFTER THE A-TUBE WAS REMOVED THE ENDOSCOPE WAS REINSERTED TO EVALUATE THE STOMACH AND ESOPHAGUS WHICH REVEALED MINIMAL DAMAGE TO THE MUCOUS MEMBRANES CONSISTENT WITH TUBE REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585442 ASPIREASSIST A-TUBE GASTROSTOMY TUBE OYF ASPIRE BARIATRICS, INC. NOT APPLICABLE 52041B

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention