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

Model Number	NOT APPLICABLE
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Missing Value Reason (3192)
Date of Event	12/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial report indicated that the skin port had separated from the a-tube.Subsequent email described the a-tube as separated at the bumper.There is no information to suggest that the a-tube which had been implanted for 20 months had any signs of material degradation.The skin port attachment to the a-tube and the a-tube overmold are both designed and tested to ensure that normal forces which might be applied to the device do not result in separation with an appropriate safety margin.Without having the device to evaluate, it is not possible to determine the root cause of this event.The patient underwent endoscopy to remove the device from the stomach.There were no issues with removal of the tube and the procedure was well tolerated.
Event or Problem Description
Patient is (b)(6) female with a history of obesity undergoing aspire assist therapy, a-tube placement in (b)(6) of 2018.Rn reported being contacted by a patient who stated that the skin port had come off and the a-tube had retracted into the stomach.

• Brand Name: ASPIREASSIST A-TUBE
• Common Device Name: GASTROSTOMY TUBE
• Manufacturer (Section D): ASPIRE BARIATRICS, INC; 319 n pottstown pike; suite 202; exton PA 19341
• MDR Report Key: 9554017
• Report Number: 3009595931-2020-00001
• Device Sequence Number: 16585220
• Product Code: OYF
• UDI-Device Identifier: 10857808005471
• UDI-Public: (01)10857808005471(17)180916(10)F100913
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P150024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: F100913
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/09/2019
• Initial Report FDA Received Date: 01/06/2020
• 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: 55 YR
• Patient Weight: 113