FDA Adverse Event
Injury
Summary report: N
PATHWAY JETSTREAM
MDR report key: 1350065
·
Received March 23, 2009
Report
- Report Number
- 3003603429-2009-00020
- Event Type
- Injury
- Date Received
- March 23, 2009
- Date of Event
- September 16, 2008
- Report Date
- March 23, 2009
- Manufacturer
- PATHWAY MEDICAL TECHNOLOGIES INC.
- Product Code
- MCX
- PMA / PMN Number
- K082186
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, 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 JETSTREAM CATHETER WAS USED TO TREAT A LONG VERY CALCIFIED SEGMENT IN THE SFA. FOLLOWING TREATMENT WITH THE JETSTREAM CATHETER AND BALLOON ANGIOPLASTY POST JETSTREAM, THE PHYSICIAN NOTED DEBRIS AT THE BIFURCATION OF THE TIBIAL ARTERIES. AN EXPORT CATHETER WAS USED TO SUCCESSFULLY ASPIRATE THE EMBOLI AND THE PATIENT WAS DISCHARGED HOME WITH NO FURTHER COMPLICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PATHWAY JETSTREAM | PERIPHERAL VASCULAR ATHERECTOMY SYSTEM | MCX | PATHWAY MEDICAL TECHNOLOGIES INC. | PV10300 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |