MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2015-09-02 for FG GATEWAY MR JP 2.00MM X 9MM M0032072109200 manufactured by Boston Scientific - Minn.
[24827178]
Device was not available to the manufacturer as it was disposed by the hospital.
Patient Sequence No: 1, Text Type: N, H10
[24827179]
Following a successful mechanical thrombectomy procedure, vessel angioplasty using the subject balloon catheter was performed. However, the angioplasty caused vascular injury which resulted in hemorrhage with subsequent acute hydrocephalus. External ventricular drainage was done but the patient expired. No further information is available.
Patient Sequence No: 1, Text Type: D, B5
[29221114]
The subject device is not available; therefore, analysis cannot be performed. However, hemorrhage, neurological symptoms and patient outcome of death are known risks associated with endovascular procedures and are noted as such in the directions for use (dfu). Therefore, a root cause of anticipated procedural complications has been assigned to this event.
Patient Sequence No: 1, Text Type: N, H10
[29221115]
Following a successful mechanical thrombectomy procedure, vessel angioplasty using the subject balloon catheter was performed. However, the angioplasty caused vascular injury which resulted in hemorrhage with subsequent acute hydrocephalus. External ventricular drainage was done but the patient expired. No further information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008853977-2015-00366 |
| MDR Report Key | 5049445 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2015-09-02 |
| Date of Report | 2015-08-10 |
| Date of Event | 2010-12-25 |
| Date Mfgr Received | 2015-09-30 |
| Date Added to Maude | 2015-09-02 |
| 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 2.00MM X 9MM |
| Generic Name | CATHETER, BALLOON TYPE |
| Product Code | PAV |
| Date Received | 2015-09-02 |
| Catalog Number | M0032072109200 |
| 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 |
| Brand Name | FG GATEWAY MR JP 2.00MM X 9MM |
| Generic Name | CATHETER, BALLOON TYPE |
| Product Code | GBA |
| Date Received | 2015-09-02 |
| Catalog Number | M0032072109200 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| 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 | 2015-09-02 |