MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-12-23 for AXIOS M00553660 5366 manufactured by Boston Scientific Corporation.
[174875778]
(b)(4). Although the suspect device has been received, the evaluation has not been completed. Therefore, the cause of the reported malfunction has not been determined. Upon 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
[174875779]
It was reported to boston scientific corporation that a hot axios stent was to be implanted transgastric to the stomach during an endoscopic ultrasound (eus) directed transgastric ercp (edge) procedure performed on (b)(6) 2019. According to the complainant, during the procedure, which the physician was attempting to deploy the first flange, the inner catheter of the delivery system protruded out the back of the handle, and the first flange failed to deploy. The delivery system was removed from the patient with the catheter fully covering the stent. A second hot axios stent was placed to complete the procedure. There were no patient complications reported as a result of this event. The patient's condition at the conclusion of the procedure was reported to be fine. Note: the hot axios stent was being implanted transgastric to the stomach during an endoscopic ultrasound (eus) directed transgastric ercp (edge) procedure; however, the hot axios stent and delivery system is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts >= 6cm in size and walled-off necrosis >= 6cm in size with >= 70% fluid content that are adherent to the gastric or bowel wall.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2019-06257 |
| MDR Report Key | 9512243 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-12-23 |
| Date of Report | 2020-03-25 |
| Date of Event | 2019-12-01 |
| Date Mfgr Received | 2020-03-06 |
| Device Manufacturer Date | 2019-09-18 |
| Date Added to Maude | 2019-12-23 |
| 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 | 2019-12-23 |
| Returned To Mfg | 2019-12-19 |
| Model Number | M00553660 |
| Catalog Number | 5366 |
| Lot Number | 0024448213 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-12-23 |