MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-01-29 for AXIOS M00553650 5365 manufactured by Boston Scientific Corporation.
[188208462]
The lot number is not known per the complainant; therefore, the device manufacture and expiration dates cannot be determined. The complainant indicated that the device has been disposed of and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed. If any further relevant information is identified, a supplemental mdr will be filed.
Patient Sequence No: 1, Text Type: N, H10
[188208463]
It was reported to boston scientific corporation that a hot axios stent was to be implanted transgastric to a pancreatic walled off necrosis (won) during a fistula formulation procedure on (b)(6) 2020. According to the complainant, during the procedure, the physician was using an alternate method of deployment where the second flange of the stent is fully deployed in the scope, and the stent is then released from the scope by manipulating the scope with a down angle right twist. However, after deploying the second flange in the scope the physician had difficulty releasing the second flange from the scope. After fully deploying the stent the position was examined with the scope and it was determined the stent was incorrectly positioned on the stomach side. The stent was reexamined with a direct-view scope and was confirmed to be completely in the stomach. The stent was removed and the procedure was aborted because the physician did not have another axios available. A 15mm stent was successfully placed the next day. There was no patient complications reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2020-00218 |
| MDR Report Key | 9644977 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-29 |
| Date of Report | 2020-01-29 |
| Date of Event | 2020-01-06 |
| Date Mfgr Received | 2020-01-07 |
| Date Added to Maude | 2020-01-29 |
| 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 | CAROLE MORLEY |
| Manufacturer Street | 300 BOSTON SCIENTIFIC WAY |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5086834015 |
| Manufacturer G1 | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Street | BALLYBRIT BUSINESS PARK |
| Manufacturer City | GALWAY |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AXIOS |
| Generic Name | PANCREATIC STENT, COVERED, METALLIC, REMOVABLE |
| Product Code | PCU |
| Date Received | 2020-01-29 |
| Model Number | M00553650 |
| Catalog Number | 5365 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | 300 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-29 |