MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-04-10 for FG GATEWAY OTW JP 2.00MM X 9MM M0032072009200 manufactured by Boston Scientific - Minn.
[72327670]
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, hemorrhage, vessel dissection, and patient outcome of death are known risks associated with endovascular procedures and are noted as such in the device directions for use (dfu). Therefore, an assignable cause of anticipated procedural complication was assigned to this event. This current report represents the initial and final report for this event. The original initial report number? 0002134265-2016-00035? For this event should be deleted from the emdr system. The information contained within this report represents information contained in the original report number listed above and any supplemental information gathered that was not previously provided to fda. The information in this current report was not provided as a supplemental report to the original report number listed above because the original initial mdr report number may now considered a duplicate report number by fda? S emdr system.? Subject device is not available.
Patient Sequence No: 1, Text Type: N, H10
[72327671]
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 | 0002134265-2017-30012 |
| MDR Report Key | 6479276 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-04-10 |
| Date of Report | 2017-04-10 |
| Date of Event | 2015-07-30 |
| Date Mfgr Received | 2016-11-22 |
| Device Manufacturer Date | 2016-10-12 |
| Date Added to Maude | 2017-04-10 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. MICHAEL REDDICK |
| 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 | 2017-04-10 |
| Catalog Number | M0032072009200 |
| Lot Number | 17347888 |
| Device Expiration Date | 2017-10-07 |
| 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 | 2017-04-10 |