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

Model Number NOT APPLICABLE

Device Problem Cut In Material (2454)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/16/2017

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

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.

• Brand Name: ASPIREASSIST A-TUBE
• Type of Device: GASTROSTOMY TUBE
• Manufacturer (Section D): ASPIRE BARIATRICS, INC.; 3200 horizon drive; suite 100; king of prussia PA 19406
• Manufacturer Contact: monica ferrante ; 3200 horizon drive; suite 100; king of prussia, PA 19406 ; 4842001031
• MDR Report Key: 6805156
• MDR Text Key: 83057753
• Report Number: 3009595931-2017-00002
• Device Sequence Number: 1
• Product Code: OYF
• 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,study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/19/2017

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: Physician
• Device Expiration Date: 08/31/2015
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: 100-0005
• Device Lot Number: 100127
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/11/2017
• Initial Date FDA Received: 08/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2013
• 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: 67 YR
• Patient Weight: 78