BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASPIREASSIST A-TUBE

    MDR report key: 6805156 · Received August 18, 2017

    Report

    Report Number
    3009595931-2017-00002
    Event Type
    Malfunction
    Date Received
    August 18, 2017
    Date of Event
    June 16, 2017
    Report Date
    July 19, 2017
    Manufacturer
    ASPIRE BARIATRICS, INC.
    Product Code
    OYF
    PMA / PMN Number
    P150024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PHOTOGRAPHS TAKEN DURING THE ENDOSCOPY TO REMOVE THE A-TUBE WERE PROVIDED TO ASPIRE AND ARE ATTACHED HERE. THE PHOTOGRAPHS SHOW THE A-TUBE SEPARATED INTO TWO PIECES AT THE FIRST ASPIRATION HOLE. THE PHOTOS ALSO SHOW THE GASTRIC PORTION OF THE A-TUBE IN ITS NORMAL POSITION RELATIVE TO THE INTERNAL BUMPER. INVESTIGATION OF THE RETURNED A-TUBE AT THE SITE OF THE SEPARATION SHOWED A CLEAN CUT BETWEEN THE TWO PIECES, WHICH WHEN PLACED TOGETHER DID NOT REVEAL ANY MATERIAL LOSS. IN ADDITION, THE INTEGRITY OF THE SILICONE MATERIAL WAS INTACT AND SHOWED NO SIGNS OF DEGRADATION IN THE MATERIAL, OR MICROBIAL INGROWTH IN THE GASTRIC PORTION OF THE A-TUBE OR BUMPER, AND CERTAINLY NONE THAT COULD EXPLAIN THE SEPARATION OF THE TUBE. FINALLY, THE DISCOLORATION ON EITHER SIDE OF THE SEPARATED TUBE INDICATES THAT THIS OCCURRED SOME TIME PRIOR TO THE ENDOSCOPY, AS DISCOLORATION HAPPENS OVER TIME AND WITH EXPOSURE TO STOMACH ACID AND STOMACH CONTENTS. THE PATIENT WAS SCHEDULED FOR AN A-TUBE REPLACEMENT DUE TO MICROBIAL INGROWTH INTO THE TUBE AT THE SKIN PORT WHICH IS A KNOWN DEGRADATION EVENT. THIS A-TUBE HAD BEEN IMPLANTED FOR 3 YEARS. HOWEVER, THIS INGROWTH AT THE SKIN PORT WAS UNRELATED TO THE FINDINGS DURING THE ENDOSCOPY. THE PATIENT HAD NOT HAD ANY PRIOR ENDOSCOPIC PROCEDURES OR ISSUES WITH BLOCKAGES OR ASPIRATION THAT MIGHT PROVIDE ANY INDICATION OF HOW THIS SEPARATION OCCURRED. ASPIRE WILL CONTINUE POST MARKET SURVEILLANCE FOR ANY SIMILAR EVENTS.

    Description of Event or Problem · 1

    DURING A ROUTINE EXCHANGE OF THE A-TUBE IT WAS NOTED THAT THE TUBE HAD SEPARATED INTO TWO PIECES AT THE GASTRIC PORTION, JUST PAST THE BUMPER, AT THE FIRST ASPIRATION HOLE. BOTH SECTIONS OF A-TUBE WERE SECURE AND THERE WAS NO INDICATION OF ANY MIGRATION OF THE TUBE SECTIONS. THE GASTRIC PORTION OF THE TUBE (OR TAIL) WAS READILY REMOVED WITH THE ENDOSCOPIC SNARE. THE STOMA SECTION OF THE A-TUBE WITH THE INTERNAL BUMPER WAS THEN REMOVED WITH SOME DIFFICULTY. THE PATIENT TOLERATED THE PROCEDURE WITH SUPERFICIAL MUCOSAL INJURY IN THE ESOPHAGUS CONSISTENT WITH REMOVAL OF THE TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584635 ASPIREASSIST A-TUBE GASTROSTOMY TUBE OYF ASPIRE BARIATRICS, INC. NOT APPLICABLE 100127

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention