MAUDE Adverse Event Report: ASPIRE BARIATRICS, INC. ASPIREASSIST A-TUBE; GASTROSTOMY TUBE

Model Number	NOT APPLICABLE
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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).
Event or Problem Description
[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.

• Brand Name: ASPIREASSIST A-TUBE
• Common Device Name: GASTROSTOMY TUBE
• Manufacturer (Section D): ASPIRE BARIATRICS, INC.; 3200 horizon drive; suite 100; king of prussia PA 19406
• MDR Report Key: 8285843
• Report Number: 3009595931-2019-00001
• Device Sequence Number: 11276739
• Product Code: OYF
• UDI-Device Identifier: 10857808005471
• UDI-Public: (01)10857808005471(17)180916(10)F100785
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P150024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/16/2018
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: 100-0011
• Device Lot Number: F100785
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/05/2019
• Initial Report FDA Received Date: 01/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 40 YR
• Patient Weight: 105