MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a study report with the FDA on 2016-05-27 for FG GATEWAY OTW US 1.50MM X 15MM M0032072215150 manufactured by Boston Scientific - Minn.
[46158347]
This report is the second out of 2. The device was disposed at the facility.
Patient Sequence No: 1, Text Type: N, H10
[46158348]
Following balloon (subject device) angioplasty, a stent was implanted to treat a 96% stenosed m1 middle cerebral artery (mca) lesion. Approximately 6 hours post procedure, it was noted that the patient mental status changed. Computed tomography (ct) scan confirmed that a massive cerebral hemorrhage resulted in a stroke with subsequent brain midline shift occurred, which led the following day to the patient's death.
Patient Sequence No: 1, Text Type: D, B5
[49857862]
The device history record review confirms that the device met all material, assembly and performance specifications. The subject device is not available; therefore, functional testing as well as physical analysis cannot be performed. However, hemorrhage, stroke and death are known risks associated with endovascular procedures and are listed as such in the device directions for use (dfu). Therefore, an assignable cause of anticipated procedural complications was assigned to this event.
Patient Sequence No: 1, Text Type: N, H10
[49857863]
Following balloon (subject device) angioplasty, a stent was implanted to treat a 96% stenosed m1 middle cerebral artery (mca) lesion. Approximately 6 hours post procedure, it was noted that the patient mental status changed. Computed tomography (ct) scan confirmed that a massive cerebral hemorrhage resulted in a stroke with subsequent brain midline shift occurred, which led the following day to the patient's death.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002134265-2016-00006 |
| MDR Report Key | 5686973 |
| Report Source | STUDY |
| Date Received | 2016-05-27 |
| Date of Report | 2016-05-02 |
| Date of Event | 2016-04-28 |
| Date Mfgr Received | 2016-07-14 |
| Device Manufacturer Date | 2013-10-21 |
| Date Added to Maude | 2016-05-27 |
| 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 OTW US 1.50MM X 15MM |
| Generic Name | CATHETER, BALLOON TYPE |
| Product Code | PAV |
| Date Received | 2016-05-27 |
| Catalog Number | M0032072215150 |
| Lot Number | 16446787 |
| 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 OTW US 1.50MM X 15MM |
| Generic Name | CATHETER, BALLOON TYPE |
| Product Code | GBA |
| Date Received | 2016-05-27 |
| Catalog Number | M0032072215150 |
| Lot Number | 16446787 |
| Device Expiration Date | 2016-10-09 |
| 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; 2. Other | 2016-05-27 |