MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-18 for ASPIREASSIST A-TUBE NOT APPLICABLE 100-0009 manufactured by Aspire Bariatrics, Inc..
[83230773]
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.
Patient Sequence No: 1, Text Type: N, H10
[83230774]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009595931-2017-00001 |
| MDR Report Key | 6805143 |
| Date Received | 2017-08-18 |
| Date of Report | 2017-03-10 |
| Date of Event | 2017-01-21 |
| Date Mfgr Received | 2017-02-09 |
| Device Manufacturer Date | 2011-07-28 |
| 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 | 4942001031 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ASPIREASSIST A-TUBE |
| Generic Name | GASTROSTOMY TUBE |
| Product Code | OYF |
| Date Received | 2017-08-18 |
| Returned To Mfg | 2017-02-16 |
| Model Number | NOT APPLICABLE |
| Catalog Number | 100-0009 |
| Lot Number | 52041B |
| 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 |