MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a study report with the FDA on 2018-04-24 for ASPIREASSIST A-TUBE NOT APPLICABLE 100-0005 manufactured by Aspire Bariatrics, Inc..
[107083701]
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.
Patient Sequence No: 1, Text Type: N, H10
[107083702]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009595931-2018-00001 |
| MDR Report Key | 7455224 |
| Report Source | STUDY |
| Date Received | 2018-04-24 |
| Date of Report | 2018-04-23 |
| Date of Event | 2018-04-06 |
| Date Mfgr Received | 2018-04-10 |
| Device Manufacturer Date | 2013-08-31 |
| Date Added to Maude | 2018-04-24 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS MONICA FERRANTE |
| Manufacturer Street | 3200 HORIZON DRIVE SUITE 100 |
| Manufacturer City | KING OF PRUSSIA PA 19406 |
| Manufacturer Country | US |
| Manufacturer Postal | 19406 |
| Manufacturer Phone | 4842001031 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ASPIREASSIST A-TUBE |
| Generic Name | GASTROSTOMY TUBE |
| Product Code | OYF |
| Date Received | 2018-04-24 |
| Returned To Mfg | 2018-04-11 |
| Model Number | NOT APPLICABLE |
| Catalog Number | 100-0005 |
| Lot Number | F100224 |
| Device Expiration Date | 2015-08-31 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ASPIRE BARIATRICS, INC. |
| Manufacturer Address | 3200 HORIZON DRIVE SUITE 100 KING OF PRUSSIA PA 19406 US 19406 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-04-24 |