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 2016-10-10 for EMBOZENE? MICROSPHERES UNK939 manufactured by .
[56919775]
Boston scientific acquired celonova on (b)(4) 2015. As part of the acquisition, a retrospective review of post-market complaints was completed by bsc on (b)(4) 2016. This specific event was not previously identified by celonova as meeting reporting criteria. When evaluated by bsc, it was assessed as meeting reporting criteria and is being reported within 30 days of the (b)(4) 2016 review. (b)(4). Device evaluated by mfr: 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
[56919776]
It was reported that the patient required a re-embolization. The patient underwent an embolization procedure of the bronchial artery using embozene microspheres. Within 48 hours of the procedure, the patient was required to undergo a re-embolization as re-bleeding was noted. The patient was noted to have multiple bronchial arteries and collaterals. The patient was reported to have done well.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2016-09556 |
| MDR Report Key | 6014120 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-10-10 |
| Date of Report | 2016-09-12 |
| Date Mfgr Received | 2016-09-12 |
| Date Added to Maude | 2016-10-10 |
| 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 | 3 |
| Event Location | 3 |
| 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 |
| 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 | 2016-10-10 |
| Model Number | UNK939 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-10-10 |