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

Model Number NOT APPLICABLE

Device Problem Material Separation (1562)

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

Event Date 04/06/2018

Event Type  malfunction  

Manufacturer Narrative

The a-tube was found in 2 pieces in the stomach.The stoma portion and bumper were securely in place.Gastric section of the tube was near the bumper and lying along the stomach wall with the top portion located in the fundus, which is normal placement for the a-tube.The tube was separated at the first aspiration hole near the bumper.Both sections of the tube were easily removed and the patient tolerated the procedure well.Visual examination of a-tube found discoloration on exposed surfaces at the point of separation indicating that the tube separation occurred over some period of time.Testing of explanted a-tubes indicates material degradation which may become significant after 3 years with regards to tensile strength and elongation at break which may increase the probability of separation prior to or during a-tube removal.Aspire will consider including a recommendation for removal/replacement at about 3 years to further reduce the probability of occurrence.

Event Description

During planned explant, endoscopy revealed a-tube was "severed" from internal bumper.The stoma portion and bumper were securely in place.Gastric section of the tube was near the bumper and lying along the stomach wall with the top portion located in the fundus, which is normal placement for the a-tube.The tube was separated at the first aspiration hole near the bumper.Both sections of the tube were easily removed and the patient tolerated the procedure well.This was a device failure.

• 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: 7455224
• MDR Text Key: 107083701
• Report Number: 3009595931-2018-00001
• 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: study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/23/2018

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: F100224
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/10/2018
• Initial Date FDA Received: 04/24/2018
• 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: 53 YR
• Patient Weight: 76