BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASPIREASSIST A-TUBE

    MDR report key: 8285843 · Received January 29, 2019

    Report

    Report Number
    3009595931-2019-00001
    Event Type
    Malfunction
    Date Received
    January 29, 2019
    Date of Event
    January 5, 2019
    Report Date
    January 29, 2019
    Manufacturer
    ASPIRE BARIATRICS, INC.
    Product Code
    OYF
    UDI-DI
    10857808005471
    PMA / PMN Number
    P150024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT UNDERWENT ENDOSCOPY FOR REMOVAL OF THE GASTRIC SEGMENT OF THE A-TUBE. THERE WERE NO ISSUES DURING THE ENDOSCOPY AND THE PATIENT TOLERATED THE PROCEDURE WELL. THE GASTRIC SEGMENT OF THE A-TUBE RETRIEVED DURING ENDOSCOPY WAS RECEIVED ON (B)(6). THE STOMA SEGMENT WITH SKIN PORT AND CONNECTOR ATTACHED WAS RECEIVED ON (B)(6). THE ENGINEERING EVALUATION INDICATES THAT THERE WAS NO MATERIAL DEGRADATION AT THE SITE OF SEPARATION AND THAT A TENSILE FORCE EXCEEDING THE DEVICE SPECIFICATION HAD BEEN APPLIED TO THE DEVICE TO CAUSE THE SEPARATION. IT IS NOT KNOWN HOW OR WHY SUCH A FORCE WAS APPLIED TO THE A-TUBE. HOWEVER, THE PATIENT GUIDE WARNS NOT TO APPLY ANY FORCE TO THE SKIN PORT OR A-TUBE. THE ENDOSCOPY REPORT AND ENGINEERING EVALUATION ARE PROVIDED IN THE (B)(4).

    Description of Event or Problem · 1

    [PATIENT (B)(6)] IS A (B)(6) YEAR OLD FEMALE WITH HISTORY OF OBESITY WITH ASPIRE DEVICE PLACEMENT IN (B)(6) 2014 (REPLACEMENT IN (B)(6) 2017) WHO PRESENTS TO THE ED WITH BROKEN DEVICE. SHE STATES THAT SHE WAS DOING ROUTINE DRAINAGE OF STOMACH CONTENTS THIS MORNING AND THE EXTERNAL DEVICE FRACTURED. SHE THEN HAD LEAKAGE OF STOMACH CONTENTS. OTHERWISE, SHE DENIES NAUSEA, VOMITING, FEVERS, CHILLS, DIARRHEA, OR CONSTIPATION. IN THE ED, PATIENT HAD GI CONSULT AND SHE WAS TRANSFERRED TO THE EDOU TO AWAIT OR FOR REMOVAL OF BROKEN DEVICE. PATIENT TO THE OPERATING ROOM AND HAD EGD AND REMOVAL OF BROKEN DEVICE. PATIENT TO FOLLOW UP OUTPATIENT WITH GASTROENTEROLOGY KNOWN TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79905 ASPIREASSIST A-TUBE GASTROSTOMY TUBE OYF ASPIRE BARIATRICS, INC. NOT APPLICABLE F100785 10857808005471

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention