MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-09 for EMBOTRAP II 5X33 REVASC. DEV. ET009533 manufactured by Neuravi Ltd..
| Report Number | 3011370111-2020-00022 |
| MDR Report Key | 9806159 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-09 |
| Date of Report | 2020-02-21 |
| Date of Event | 2020-02-11 |
| Date Mfgr Received | 2020-02-20 |
| Device Manufacturer Date | 2019-08-06 |
| Date Added to Maude | 2020-03-09 |
| 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 | MR. GABRIEL ALFAGEME |
| Manufacturer Street | 31 TECHNOLOGY DRIVE |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 949789-868 |
| Manufacturer G1 | ADVANT MEDICAL |
| Manufacturer Street | PARKMORE BUSINESS PARK WEST |
| Manufacturer City | GALWAY H91 PV0V |
| Manufacturer Country | EI |
| Manufacturer Postal Code | H91 PV0V |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EMBOTRAP II 5X33 REVASC. DEV. |
| Generic Name | CATHETER, THROMBUS RETRIEVER |
| Product Code | NRY |
| Date Received | 2020-03-09 |
| Returned To Mfg | 2020-03-03 |
| Model Number | ET009533 |
| Catalog Number | ET009533 |
| Lot Number | 19K183AV |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NEURAVI LTD. |
| Manufacturer Address | BLOCK 3 BALLYBRITT BUSINESS PARK GALWAY H91 K5YD EI H91 K5YD |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-09 |