MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a study report with the FDA on 2019-01-29 for ASPIREASSIST A-TUBE NOT APPLICABLE 100-0011 manufactured by Aspire Bariatrics, Inc..
[136722331]
The subject underwent endoscopy for removal of the gastric segment of the a-tube. There were no issues during the endoscopy and the patient tolerated the procedure well. The gastric segment of the a-tube retrieved during endoscopy was received on (b)(6). The stoma segment with skin port and connector attached was received on (b)(6). The engineering evaluation indicates that there was no material degradation at the site of separation and that a tensile force exceeding the device specification had been applied to the device to cause the separation. It is not known how or why such a force was applied to the a-tube. However, the patient guide warns not to apply any force to the skin port or a-tube. The endoscopy report and engineering evaluation are provided in the (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[136722332]
[patient (b)(6)] is a (b)(6) year old female with history of obesity with aspire device placement in (b)(6) 2014 (replacement in (b)(6) 2017) who presents to the ed with broken device. She states that she was doing routine drainage of stomach contents this morning and the external device fractured. She then had leakage of stomach contents. Otherwise, she denies nausea, vomiting, fevers, chills, diarrhea, or constipation. In the ed, patient had gi consult and she was transferred to the edou to await or for removal of broken device. Patient to the operating room and had egd and removal of broken device. Patient to follow up outpatient with gastroenterology known to patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009595931-2019-00001 |
| MDR Report Key | 8285843 |
| Report Source | STUDY |
| Date Received | 2019-01-29 |
| Date of Report | 2019-01-29 |
| Date of Event | 2019-01-05 |
| Date Mfgr Received | 2019-01-05 |
| Device Manufacturer Date | 2015-09-16 |
| Date Added to Maude | 2019-01-29 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | 2019-01-29 |
| Returned To Mfg | 2019-01-08 |
| Model Number | NOT APPLICABLE |
| Catalog Number | 100-0011 |
| Lot Number | F100785 |
| Device Expiration Date | 2018-09-16 |
| Operator | LAY USER/PATIENT |
| 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 | 2019-01-29 |