MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-06-01 for FG GATEWAY OTW US 1.50MM X 9MM M0032072209150 manufactured by Boston Scientific - Minn.
[46324524]
Subject device is not available.
Patient Sequence No: 1, Text Type: N, H10
[46324645]
Following percutaneous transluminal angioplasty (pta) using a balloon catheter (subject device), a stent was placed across the target lesion. Post procedure, the patient suffered a reperfusion hemorrhage. The patient died. The physician believed that the death was unrelated to the subject device. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5
[48512373]
Patient Sequence No: 1, Text Type: N, H10
[48512374]
Following percutaneous transluminal angioplasty (pta) using a balloon catheter (subject device), a stent was placed across the target lesion. Post procedure, the patient suffered a reperfusion hemorrhage. The patient died 9 days after the procedure. The physician believed that the death was unrelated to the subject device. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5
[51296286]
The device history record (dhr) review confirms that the device met all material, assembly and performance specifications. The subject device was not returned for analysis; therefore, physical as well as a functional testing could not be performed. However, patient hemorrhage, blood loss with sequelae and death are known risks associated with endovascular procedures and noted as such in the device directions for use (dfu). Therefore, an assignable cause of anticipated procedural complication was assigned to this event.
Patient Sequence No: 1, Text Type: N, H10
[51296287]
Following percutaneous transluminal angioplasty (pta) using a balloon catheter (subject device), a stent was placed across the target lesion. Post procedure, the patient suffered a reperfusion hemorrhage. The patient died 9 days after the procedure. The physician believed that the death was unrelated to the subject device. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002134265-2016-00008 |
| MDR Report Key | 5692460 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-06-01 |
| Date of Report | 2016-05-05 |
| Date of Event | 2015-08-24 |
| Date Mfgr Received | 2016-07-18 |
| Device Manufacturer Date | 2012-10-30 |
| Date Added to Maude | 2016-06-01 |
| 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 9MM |
| Generic Name | CATHETER, BALLOON TYPE |
| Product Code | PAV |
| Date Received | 2016-06-01 |
| Catalog Number | M0032072209150 |
| Lot Number | 15600433 |
| Device Expiration Date | 2015-10-11 |
| 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 |
| Brand Name | FG GATEWAY OTW US 1.50MM X 9MM |
| Generic Name | CATHETER, BALLOON TYPE |
| Product Code | GBA |
| Date Received | 2016-06-01 |
| Catalog Number | M0032072209150 |
| Lot Number | 15600433 |
| Device Expiration Date | 2015-10-11 |
| 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 | 2016-06-01 |