FDA Adverse Event
Injury
Summary report: N
JETSTREAM G3
MDR report key: 1924329
·
Received December 7, 2010
Report
- Report Number
- 3003603429-2010-00052
- Event Type
- Injury
- Date Received
- December 7, 2010
- Date of Event
- November 6, 2010
- Report Date
- December 7, 2010
- Manufacturer
- PATHWAY MEDICAL TECHNOLOGIES, INC.
- Product Code
- MCW
- PMA / PMN Number
- K101221
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, 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 40 CM OCCLUDED SUPERFICIAL FEMORAL ARTERY (SFA). WIRED THE SFA AND PROCEEDED WITH THE DEVICE; HOWEVER, THERE WAS NO ASPIRATION DURING THE CASE, THOUGHT DUE TO OCCLUSION EMBOLIZATION OCCURRED AND AN EXTRACTION DEVICE WAS USED TO SUCCESSFULLY REMOVE EMBOLI. PT IS DOING OK.
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 |