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

Model Number NOT APPLICABLE

Device Problem Material Integrity Problem (2978)

Patient Problem Missing Value Reason (3192)

Event Date 12/07/2019

Event Type  malfunction  

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 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
• Type of Device: GASTROSTOMY TUBE
• Manufacturer (Section D): ASPIRE BARIATRICS, INC; 319 n pottstown pike; suite 202; exton PA 19341
• Manufacturer Contact: monica ferrante ; 319 n pottstown pike; suite 202; exton, PA 19341 ; 4842001031
• MDR Report Key: 9554017
• MDR Text Key: 182704441
• Report Number: 3009595931-2020-00001
• Device Sequence Number: 1
• Product Code: OYF
• UDI-Device Identifier: 10857808005471
• UDI-Public: (01)10857808005471(17)180916(10)F100913
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/09/2019
• Initial Date FDA Received: 01/06/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/15/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Weight: 113