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 2020-01-02 for AXIOS M00553650 5365 manufactured by Boston Scientific Corporation.
[183916071]
The complainant was unable to report the lot number; therefore, the manufacture date and expiration date are unknown. However, the complainant reported that the device was not expired. Report source: e7121 axios japan post market survey. (b)(4). The complainant indicated that the device is contaminated 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
[183916072]
It was reported to boston scientific corporation that a hot axios stent was implanted in a transgastric position to treat a pancreatic walled-off necrosis (won) during a stent placement procedure performed on (b)(6) 2019. Reportedly, the patient's pseudocyst was measured on (b)(6) 2019 and was confirmed to be 170mm in diameter, in close contact with the stomach wall, and contained 80% liquid content. The won was located from the pancreatic body to the pancreatic tail. The stent was placed as part of the e7121 axios japan post market survey. Reportedly, five necrosectomy procedures were performed on unknown dates after the stent placement procedure. According to the complainant, on (b)(6) 2019, the patient had a fever over 38 degrees celsius, and the stent was noted to be occluded. On (b)(6) 2019, the stent was removed from the patient. There were no patient complications reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2019-06350 |
| MDR Report Key | 9540071 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-02 |
| Date of Report | 2020-01-02 |
| Date of Event | 2019-05-06 |
| Date Mfgr Received | 2019-12-09 |
| Date Added to Maude | 2020-01-02 |
| 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 | 2020-01-02 |
| 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 | 2020-01-02 |