MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,03,05,07 report with the FDA on 2015-02-10 for CONTOUR PVA MICROSPHERES UNK90 manufactured by Boston Scientific - Cork.
[5333520]
Reported via journal article. It was reported that biloma occurred. In a study to compare the efficacy of right portal vein embolization using particles only versus particle and additional central plug and/or coil. Extrahepatic biloma after portal vein embolization occurred. This was treated with ct-guided percutaneous drainage and did not prohibit the planned resection.
Patient Sequence No: 1, Text Type: D, B5
[12837564]
Literature citation: geisel, dominik, et. Al. "improved hypertrophy of future remnant liver after protal vein embolization with plugs, coils and particles"; cardiovascular interventional radiology (2014) 37:1251-1258. It is indicated that the device will not be returned for evaluation. A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted. If there is any further relevant information from that review, a supplemental medwatch will be filed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2134265-2015-00424 |
| MDR Report Key | 4502350 |
| Report Source | 01,03,05,07 |
| Date Received | 2015-02-10 |
| Date of Report | 2015-01-14 |
| Date Mfgr Received | 2015-01-14 |
| Date Added to Maude | 2015-02-10 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | EMP. LINDA LEIMER |
| Manufacturer Street | ONE SCIMED PLACE |
| Manufacturer City | MAPLE GROVE MN 55311 |
| Manufacturer Country | US |
| Manufacturer Postal | 55311 |
| Manufacturer Phone | 7634941700 |
| Manufacturer G1 | BOSTON SCIENTIFIC - CORK |
| Manufacturer Street | BUSINESS AND TECHNOLOGY PARK MODEL FARM ROAD |
| Manufacturer City | CORK |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CONTOUR PVA MICROSPHERES |
| Generic Name | AGENTS, EMBOLIC, FOR TREATMENT OF UTERINE FIBROIDS |
| Product Code | NAJ |
| Date Received | 2015-02-10 |
| Model Number | UNK90 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC - CORK |
| Manufacturer Address | BUSINESS AND TECHNOLOGY PARK MODEL FARM ROAD CORK EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-02-10 |