FDA Adverse Event
Injury
Summary report: N
QUICKSEAL CCS ARTERIAL CLOSURE SYSTEM
MDR report key: 445663
·
Received February 27, 2003
Report
- Report Number
- 2134280-2003-00001
- Event Type
- Injury
- Date Received
- February 27, 2003
- Date of Event
- December 2, 2002
- Report Date
- February 27, 2003
- Manufacturer
- SUB-Q, INC.
- Product Code
- MGB
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE PT WAS TREATED WITH THE QS ARTERIAL CLOSURE SYSTEM IN 2002 TO ACHIEVE HEMOSTASIS AT THE ARTERIAL PUNCTURE SITE FOLLOWING A CATHERIZATION PROCEDURE. HEMOSTASIS WAS ACHIEVED AFTER APPLYING MANUAL PRESSURE AT THE PUNCTURE SITE. NO COMPLICATIONS WERE NOTED AT THAT TIME. IN 12/2002, THE PT WAS DIAGNOSED WITH A PSEUDOANEURYSM AT THE SAME PUNCTURE SITE AND SURGERY WAS PERFORMED ON THE SAME DAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | QUICKSEAL CCS ARTERIAL CLOSURE SYSTEM | VASCULAR HEMOSTASIS DEVICE | MGB | SUB-Q, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |