MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-08-12 for FG GATEWAY MR JP 3.50MM X 12MM M0032072112350 manufactured by Boston Scientific - Minn.
[116856796]
This is the fourth of 4 reports. Subject device is not available.
Patient Sequence No: 1, Text Type: N, H10
[116856797]
Patient successfully underwent intracranial stenting with stent microcatheter and balloon catheters (subject device) on the internal carotid artery (ic) with stenosis rate of 80% and lesion length of 10 mm. Next day magnetic resonance imaging (mri t2) weighted image showed unknown black void on right brain. However, the same level of ct image showed no sign. According to the physician, the black void indicates metal artifact of some metal which was used in the procedure, possibly fragments of coating or a part of product components. The patient was asymptomatic.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008853977-2018-00040 |
| MDR Report Key | 7775639 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-08-12 |
| Date of Report | 2018-08-15 |
| Date of Event | 2018-06-20 |
| Date Mfgr Received | 2018-08-14 |
| Device Manufacturer Date | 2016-12-22 |
| Date Added to Maude | 2018-08-12 |
| 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. TARA LOPEZ |
| 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 3.50MM X 12MM |
| Generic Name | CATHETER, BALLOON TYPE |
| Product Code | GBA |
| Date Received | 2018-08-12 |
| Catalog Number | M0032072112350 |
| Lot Number | 20101486 |
| Device Expiration Date | 2019-12-22 |
| 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. Other | 2018-08-12 |