MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2015-12-30 for FG GATEWAY MR JP 2.50MM X 9MM M0032072109250 manufactured by Boston Scientific - Minn.
[34734343]
The subject device is not available.
Patient Sequence No: 1, Text Type: N, H10
[34734344]
It was reported in a post market surveillance case that thrombectomy with the retriever was performed for a cardiogenic occlusion in the basilar artery. The artery did not recanalize. Angioplasty was done with the subject device and hydrocephalus due to intracranial hemorrhage occurred. Cerebral ventricle drainage was performed but the patient died.
Patient Sequence No: 1, Text Type: D, B5
[39036684]
The device history record review could not be performed because the lot number of the device is not known. The device was not returned for analysis therefore visual inspection and functional testing could not be performed. From the information provided there was no indication that the device was not used as in accordance with the labeling or that this caused or contributed to the reported event. Patient hemorrhage and death are known and anticipated complications to these types of procedures and are noted in the labeling. Therefore, it was determined that the reported event was an anticipated procedural complication.
Patient Sequence No: 1, Text Type: N, H10
[39036725]
It was reported in a post market surveillance case that thrombectomy with the retriever was performed for a cardiogenic occlusion in the basilar artery. The artery did not recanalize. Angioplasty was done with the subject device and hydrocephalus due to intracranial hemorrhage occurred. Cerebral ventricle drainage was performed but the patient died.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008853977-2015-00553 |
| MDR Report Key | 5336719 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2015-12-30 |
| Date of Report | 2015-12-07 |
| Date of Event | 2012-04-13 |
| Date Mfgr Received | 2016-01-28 |
| Date Added to Maude | 2015-12-30 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. SANDA DRACIC |
| Manufacturer Street | 47900 BAYSIDE PARKWAY |
| Manufacturer City | FREMONT CA 94538 |
| Manufacturer Country | US |
| Manufacturer Postal | 94538 |
| Manufacturer Phone | 5104132500 |
| Manufacturer G1 | BOSTON SCIENTIFIC - MINN |
| Manufacturer Street | ONE 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 | FG GATEWAY MR JP 2.50MM X 9MM |
| Generic Name | CATHETER, BALLOON TYPE |
| Product Code | PAV |
| Date Received | 2015-12-30 |
| Catalog Number | M0032072109250 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC - MINN |
| Manufacturer Address | ONE SCIMED PLACE MAPLE GROVE MN 55311 US 55311 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Other; 3. Required No Informationntervention | 2015-12-30 |