FDA Adverse Event
Other
Summary report: N
PENUMBRA SYSTEM REPERFUSION CATHETER 041
MDR report key: 1661800
·
Received April 16, 2010
Report
- Report Number
- 3005168196-2010-00473
- Event Type
- Other
- Date Received
- April 16, 2010
- Date of Event
- August 27, 2009
- Report Date
- March 12, 2010
- Manufacturer
- PENUMBRA, INC.
- Product Code
- NRY
- PMA / PMN Number
- K072718
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE PHYSICIAN COULD NOT CONFIRM THE RELATIONSHIP OF THE EVENT TO THE DEVICE.
Description of Event or Problem · 1
DURING TREATMENT OF A PT WITH THE PSC041, AN ANGIOGRAM DEMONSTRATED EXTENSIVE VASOSPASM OF THE DISTAL CERVICAL LEFT INTERNAL CAROTID ARTERY. THEREFORE, 5MG OF VERAPAMIL WAS ADMINISTERED INTRA-ARTERIALLY. THIS WAS DEEMED NOT SERIOUS BY THE PHYSICIAN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PENUMBRA SYSTEM REPERFUSION CATHETER 041 | PERCUTANEOUS CATHETER | NRY | PENUMBRA, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |