FDA Adverse Event
Injury
Summary report: N
GATEWAY PTA DILATION CATHETER
MDR report key: 1211501
·
Received October 22, 2008
Report
- Report Number
- 2939204-2008-00488
- Event Type
- Injury
- Date Received
- October 22, 2008
- Date of Event
- February 27, 2008
- Report Date
- October 13, 2008
- Manufacturer
- NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORP.
- Product Code
- GBA
- PMA / PMN Number
- H050001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
VESSEL DISSECTION. NO ALLEGATION OF PRODUCT MALFUNCTION OR NON CONFORMANCE CONTRIBUTING TO THE REPORTED EVENT.
Description of Event or Problem · 1
PATIENT PRESENTED WITH SYMPTOMS OF VERTEBRAL-BASILAR HYPOPERFUSION AND ANGIOGRAPHY REVEALED NEAR TOTAL OCCLUSION OF THE RIGHT BASILAR ARTERY. FOLLOWING SEQUENTIAL ANGIOPLASTY USING TWO PTA DILATION CATHETERS AND THE PLACEMENT OF A STENT, ANGIOGRAPHY REVEALED A DISSECTION IN THE RIGHT VERTEBRAL ARTERY. A SECOND STENT WAS PLACED TO TREAT THE VESSEL DISSECTION AND THERE WERE NO CLINICAL SYMPTOMS ASSOCIATED WITH THE EVENT. THERE WAS SIGNIFICANT IMPROVEMENT IN THE PRESENTING SYMPTOMS AND THE PATIENT IS REPORTED TO BE FUNCTIONALLY INDEPENDENT AT HOME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GATEWAY PTA DILATION CATHETER | (GBA) DILATATION BALLOON CATHETER | GBA | NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORP. | 20722-0915 | 9377048 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Required Intervention | A GATEWAY PTA DILATION CATHETER| TWO WINGSPAN STENTS (BOSTON SCIENTIFIC) |