FDA Adverse Event
Injury
Summary report: N
JETSTREAM G3
MDR report key: 1760578
·
Received July 14, 2010
Report
- Report Number
- 3003603429-2010-00025
- Event Type
- Injury
- Date Received
- July 14, 2010
- Date of Event
- June 15, 2010
- Report Date
- July 14, 2010
- Manufacturer
- PATHWAY MEDICAL TECHNOLOGIES INC.
- Product Code
- MCW
- PMA / PMN Number
- K101221
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE PATHWAY JETSTREAM G3 CATHETER WAS DISCARDED AFTER THE PROCEDURE AND THEREFORE, NOT RETURNED TO PATHWAY MEDICAL TECHNOLOGIES FOR EVAL. DISTAL EMBOLI IS AN INHERENT RISK FOR THE TREATMENT OF PERIPHERAL VASCULAR DISEASE WITH PATHWAY MEDICAL'S JETSTREAM G3 SYSTEM AND IS LISTED AS A POTENTIAL ADVERSE EVENT IN THE IFU.
Description of Event or Problem · 1
THE JETSTREAM G3 WAS ADVANCED TO TREAT A 10CM LESION LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA) AND POPLITEAL. MILD DISTAL EMBOLIZATION WAS SEEN FOLLOWING THE PROCEDURE. DISTAL EMBOLI WAS TREATED WITH A THROMBOLYTIC AGENT AND THE PT WAS FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | JETSTREAM G3 | PERIPHERAL VASCULAR ATHERECTOMY SYSTEM | MCW | PATHWAY MEDICAL TECHNOLOGIES INC. | PV31300 | 100514 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |