MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,study report with the FDA on 2017-08-18 for ASPIREASSIST A-TUBE NOT APPLICABLE 100-0005 manufactured by Aspire Bariatrics, Inc..
[83057753]
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.
Patient Sequence No: 1, Text Type: N, H10
[83057754]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009595931-2017-00002 |
| MDR Report Key | 6805156 |
| Report Source | HEALTH PROFESSIONAL,STUDY |
| Date Received | 2017-08-18 |
| Date of Report | 2017-07-19 |
| Date of Event | 2017-06-16 |
| Date Mfgr Received | 2017-07-11 |
| Device Manufacturer Date | 2013-08-31 |
| Date Added to Maude | 2017-08-18 |
| 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 | 2017-08-18 |
| Returned To Mfg | 2017-06-19 |
| Model Number | NOT APPLICABLE |
| Catalog Number | 100-0005 |
| Lot Number | 100127 |
| 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 | 2017-08-18 |