FDA Adverse Event
Injury
Summary report: N
JETSTREAM G3
MDR report key: 1970501
·
Received January 20, 2011
Report
- Report Number
- 3003603429-2011-00002
- Event Type
- Injury
- Date Received
- January 20, 2011
- Date of Event
- December 21, 2010
- Report Date
- January 20, 2011
- Manufacturer
- PATHWAY MEDICAL TECHNOLOGIES, INC.
- Product Code
- MCW
- PMA / PMN Number
- K101221
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, 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 EMBOLIZATION 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 LONG SEGMENT OF THROMBUS FROM THE SUPERFICIAL FEMORAL ARTERY (SFA) DOWN TO THE DISTAL POSTERIOR TIBIAL (PT). THE DEVICE WAS RUN FOR 10 MINUTES 20 SECONDS WITH MULTIPLE INSERTIONS. DISTAL EMBOLI WAS NOTED IN THE DISTAL PT AND REMOVED WITH ASPIRATION CATHETER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | JETSTREAM G3 | PERIPHERAL VASCULAR ATHERECTOMY SYSTEM | MCW | PATHWAY MEDICAL TECHNOLOGIES, INC. | PV31300 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |