MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-12-13 for FG GATEWAY OTW JP 2.00MM X 9MM M0032072009200 manufactured by Boston Scientific - Minn.
[62226576]
Subject device is not available.
Patient Sequence No: 1, Text Type: N, H10
[62226577]
It was reported that during percutaneous transluminal angioplasty procedure (pta) at 9 atm for 30 seconds for a left mca stenosis (91. 6% occlusion and lesion length of 4. 6mm) with the subject device, dissection occurred at the lesion location. Medical intervention was performed by placement of a stent system. Hyperperfusion was observed immediately after angiography. Five hours and a half post- procedure the patient developed putaminal hemorrhage and expired. No medical treatment was performed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002134265-2016-00035 |
| MDR Report Key | 6169702 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-12-13 |
| Date of Report | 2016-11-22 |
| Date of Event | 2015-07-30 |
| Date Mfgr Received | 2016-11-22 |
| Date Added to Maude | 2016-12-13 |
| 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. 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 OTW JP 2.00MM X 9MM |
| Generic Name | CATHETER, BALLOON TYPE |
| Product Code | PAV |
| Date Received | 2016-12-13 |
| Catalog Number | M0032072009200 |
| Lot Number | 17347888 |
| 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 | 2016-12-13 |