FDA Adverse Event
Injury
Summary report: N
PATHWAY JETSTREAM
MDR report key: 1341748
·
Received March 11, 2009
Report
- Report Number
- 3003603429-2009-00015
- Event Type
- Injury
- Date Received
- March 11, 2009
- Date of Event
- February 9, 2009
- Report Date
- March 11, 2009
- Manufacturer
- PATHWAY MEDICAL TECHNOLOGIES INC.
- Product Code
- MCX
- PMA / PMN Number
- K082186
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE JETSTREAM CATHETER WAS DISCARDED AFTER THE PROCEDURE AND THEREFORE NOT RETURNED TO PATHWAY MEDICAL TECHNOLOGIES FOR EVALUATION.
Description of Event or Problem · 1
THE PATHWAY JETSTREAM DEVICE WAS USED TO TREAT A 10CM MODERATELY CALCIFIED LESION IN THE SFA. AFTER MULTIPLE PASSES IN BOTH THE MINIMUM AND MAXIMUM DIAMETER MODE A SLIGHT NON FLOW LIMITING DISSECTION WAS OBSERVED. IT WAS SUCCESSFULLY TREATED WITH A BALLOON AND THE PATIENT WAS FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PATHWAY JETSTREAM | PERIPHERAL ATHERECTOMY CATHETER | MCX | PATHWAY MEDICAL TECHNOLOGIES INC. | PV10300 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Required Intervention |