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 2020-01-06 for AXIOS M00553650 5365 manufactured by Boston Scientific Corporation.
[174469090]
Patient's exact age is unknown; however, it was reported that the patient was over the age of 18. (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
[174469091]
It was reported to boston scientific corporation that a hot axios stent was to be implanted in a transgastric position to treat a pancreatic pseudocyst during a procedure performed on (b)(6) 2019. According to the complainant, during the procedure, after the second flange of the stent was deployed into the scope, the stent was pushed out of the scope and into the cyst and ended up fully deployed in the abdominal cavity. The complainant provided photographs of the delivery system post-deployment, which show the inner shaft was kinked. Following the procedure, computed tomography (ct) imaging was performed, confirming that the stent had been misplaced. The patient was sent to surgery, during which the stent was removed from the patient. As of (b)(6) 2019, the patient's condition was reported to be stable, and there were plans to discharge the patient from the intensive care unit (icu) within the next few days.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2019-06417 |
| MDR Report Key | 9554598 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-06 |
| Date of Report | 2020-02-20 |
| Date of Event | 2019-12-09 |
| Date Mfgr Received | 2020-01-28 |
| Device Manufacturer Date | 2019-09-04 |
| Date Added to Maude | 2020-01-06 |
| 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 | 2020-01-06 |
| Returned To Mfg | 2020-01-14 |
| Model Number | M00553650 |
| Catalog Number | 5365 |
| Lot Number | 0024373206 |
| 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. Hospitalization; 2. Required No Informationntervention | 2020-01-06 |