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

Model Number NOT APPLICABLE

Device Problems Material Separation (1562); Torn Material (3024)

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

Event Date 01/21/2017

Event Type  malfunction  

Manufacturer Narrative

There have been a significant number of tube replacements or removals and this is the first such event to be reported.Material separation has been anticipated in the a-tube risk assessment and mitigated as far as possible by design and testing of the a-tube, and assessment of the risks associated with removal of separated pieces of the a-tube by endoscopic means.What has been learned as a result of this event is that placement of the snare may be important particularly in older implants.As a result the instructions for a-tube removal are being revised to specify placement of the snare as an additional means of risk reduction.The clinicians are now reminded not to attach the snare at the aspiration holes but rather at the full circumference of the a-tube for more secure purchase during removal.

Event Description

During the procedure where the a-tube was removed, the a-tube split into 2 sections in esophagus.After removal of the small piece the gastroscope was used again to remove the second part.No problems reported for the patient.After the a-tube was removed the endoscope was reinserted to evaluate the stomach and esophagus which revealed minimal damage to the mucous membranes consistent with tube removal.

• 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 ; 4942001031
• MDR Report Key: 6805143
• MDR Text Key: 83230773
• Report Number: 3009595931-2017-00001
• Device Sequence Number: 1
• Product Code: OYF
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: P150024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: 100-0009
• Device Lot Number: 52041B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/28/2011
• 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: 56 YR
• Patient Weight: 65