MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2015-12-30 for FG GATEWAY MR JP 2.00MM X 9MM M0032072109200 manufactured by Boston Scientific - Minn.
[34708896]
The subject device was disposed of at the hospital.
Patient Sequence No: 1, Text Type: N, H10
[34708897]
It was reported that during percutaneous transluminal angioplasty (pta) with the balloon catheter (subject device), middle cerebral artery dissection and bleeding occurred. No additional treatment was performed and the patient later died. No further information is available.
Patient Sequence No: 1, Text Type: D, B5
[38857809]
The device history record review was unable to be performed as the lot number of the device was not reported. The subject device is not available; therefore, analysis cannot be performed. From the information available, there is no indication that the reported event is related to product specifications nonconformance or misuse. There is also no indication that the subject device malfunctioned. However, death, vessel dissection and hemorrhage are known risks associated with such procedures and noted as such in the directions for use (dfu). Therefore, a root cause of anticipated procedural complications has been assigned to the event.
Patient Sequence No: 1, Text Type: N, H10
[38857810]
It was reported that during percutaneous transluminal angioplasty (pta) with the balloon catheter (subject device), middle cerebral artery dissection and bleeding occurred. No additional treatment was performed and the patient later died. No further information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008853977-2015-00549 |
| MDR Report Key | 5336125 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2015-12-30 |
| Date of Report | 2015-12-07 |
| Date of Event | 2011-06-01 |
| Date Mfgr Received | 2016-01-28 |
| Date Added to Maude | 2015-12-30 |
| 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 | 2015-12-30 |
| Catalog Number | M0032072109200 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2015-12-30 |