MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-01-31 for FG GATEWAY OTW OUS 2.00MM X 15MM M0032072415200 manufactured by Boston Scientific - Minn.
[4088752]
It was reported that a patient presented with 72% stenosis in the right m1 middle cerebral artery (mca). The subject device was advanced into the stenosed lesion and inflated to 6 atm. The device was removed and the stenosis was not improved. The device was readvanced and reinflated to 8 atm. The stenosis seemed to be improved under angiography and the device was removed. However, the ct-scan showed a hemorrhage. The hemorrhage resulted in a stroke. The patient was treated with aspirin, lipitor and liusuanqinglupigelei pian. One day post procedure the patient passed away.
Patient Sequence No: 1, Text Type: D, B5
[11489731]
Device was disposed.
Patient Sequence No: 1, Text Type: N, H10
[18867671]
It was reported that a patient presented with 72% stenosis in the right m1 middle cerebral artery (mca). The subject device was advanced into the stenosed lesion and inflated to 6 atm. The device was removed and the stenosis was not improved. The device was readvanced and reinflated to 8 atm. The stenosis seemed to be improved under angiography and the device was removed. However, the ct-scan showed a hemorrhage. The hemorrhage resulted in a stroke. The patient was treated with aspirin, lipitor and liusuanqinglupigelei pian. One day post procedure the patient passed away.
Patient Sequence No: 1, Text Type: D, B5
[19213863]
The device history record review confirms that the device met all material, assembly and performance specifications. The device was not returned; therefore, analysis cannot 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, stroke 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
| Report Number | 3008853977-2014-00034 |
| MDR Report Key | 3601524 |
| Report Source | 05 |
| Date Received | 2014-01-31 |
| Date of Report | 2014-01-14 |
| Date of Event | 2014-01-14 |
| Date Mfgr Received | 2014-02-21 |
| Date Added to Maude | 2014-01-31 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. ALYSON HARRIS |
| 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 OUS 2.00MM X 15MM |
| Generic Name | CATHETER, BALLOON TYPE |
| Product Code | PAV |
| Date Received | 2014-01-31 |
| Catalog Number | M0032072415200 |
| Lot Number | 16177380 |
| 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 | 2014-01-31 |