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 2018-08-17 for EMBOZENE MICROSPHERES manufactured by Boston Scientific Corporation.
[117561406]
Event date: no event date was provided. Therefore the event date was populated with the first date of the month of the aware date. Initial reporter phone number: (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[117561407]
It was reported that the patient experienced a gastrointestinal (gi) bleed, dark feces, and some challenges with the biliary duct. Embozene microspheres (40 um) was selected for use during a liver embolization/bland-tace procedure for a patient with liver cancer. No malfunction was reported to have occurred during the procedure. However, afterwards, the doctor reported that the patient had an adverse event of gi bleed, dark feces and some challenges with the biliary duct; believed to be due to the embozene 40 um. No other complications were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2018-60053 |
| MDR Report Key | 7795112 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-08-17 |
| Date of Report | 2018-08-17 |
| Date of Event | 2018-07-01 |
| Date Mfgr Received | 2018-07-25 |
| Date Added to Maude | 2018-08-17 |
| 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 | SONALI ARANGIL |
| Manufacturer Street | TWO SCIMED PLACE |
| Manufacturer City | MAPLE GROVE MN 55311 |
| Manufacturer Country | US |
| Manufacturer Postal | 55311 |
| Manufacturer Phone | 6515827403 |
| Manufacturer G1 | BOSTON SCIENTIFIC SCIMED, INC |
| Manufacturer Street | TWO SCIMED PLACE |
| Manufacturer City | MAPLE GROVE MN 55311 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55311 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EMBOZENE MICROSPHERES |
| Generic Name | EMBOLIC DEVICE |
| Product Code | NAJ |
| Date Received | 2018-08-17 |
| 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 | TWO SCIMED PLACE MAPLE GROVE MN 55311 US 55311 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-08-17 |