FDA Adverse Event
Injury
Summary report: N
VASO-SEAL
MDR report key: 555656
·
Received February 4, 2004
Report
- Report Number
- 555656
- Event Type
- Injury
- Date Received
- February 4, 2004
- Date of Event
- January 29, 2004
- Report Date
- February 4, 2004
- Manufacturer
- DATASCOPE CORPORATION
- Product Code
- MGB
- Adverse Event
- Yes
- Report Source
- User Facility report
- Reporter Location
- GA, US
Narratives
Description of Event or Problem · 1
A PATIENT EXPERIENCED DECREASE IN PULSES ON THE RIGHT, WITH SOME TINGLING/PAIN IN THE RIGHT FOOT. THE RIGHT LEG WAS COOLER THAN THE LEFT. THERE WAS NO OBVIOUS SIGNS OF ISCHEMIA. THE PATIENT WAS TAKEN FOR AORTA BIFEMURAL RUNOFF WHICH SHOWED A THROMBUS AT THE DISTAL POPLITEAL ARTERY. THE PATIENT THEN UNDERWENT A EMBOLECTOMY OF THE RIGHT POPLITEAL ARTERY. A SPECIMEN WAS SENT TO PATHOLOGY. QUESTION AS TO WHETER VASO-SEAL BROKE DURING PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VASO-SEAL | HEMOSTASIS DEVICE | MGB | DATASCOPE CORPORATION | UNK | 10213741 OR 10143741 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Required Intervention | NO OTHER THERAPIES |