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 2020-01-17 for AXIOS M00553640 5364 manufactured by Boston Scientific Corporation.
[176058496]
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. (b)(4). Although expected, the device has not been received for analysis. Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Patient Sequence No: 1, Text Type: N, H10
[176058497]
It was reported to boston scientific corporation that a hot axios stent was implanted in a transgastric position to treat a pancreatic juice leakage during an endoscopic ultrasound (eus) procedure performed on (b)(6) 2019. Reportedly, the implantation site was examined with eus doppler prior to placing the stent. According to the complainant, on (b)(6) 2019, the patient experienced bleeding from the cyst. On (b)(6) 2019, the patient was examined with an upper endoscope, and it was noted that blood clots had accumulated in the axios stent. The physician attempted to remove the stent using grasping forceps, but the patient began bleeding. The procedure was not completed, and the patient was sent to the angiography room to receive treatment for the bleed. The patient's condition at the conclusion of the procedure was reported to be stable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2020-00086 |
| MDR Report Key | 9604353 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-17 |
| Date of Report | 2020-01-17 |
| Date of Event | 2019-12-21 |
| Date Mfgr Received | 2019-12-23 |
| Date Added to Maude | 2020-01-17 |
| 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 | 2020-01-17 |
| Model Number | M00553640 |
| Catalog Number | 5364 |
| 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 | 2020-01-17 |