FDA Adverse Event
Malfunction
Summary report: N
SUTURE TRIMMER KP+T
MDR report key: 378781
·
Received February 21, 2002
Report
- Report Number
- 2953144-2002-00022
- Event Type
- Malfunction
- Date Received
- February 21, 2002
- Date of Event
- January 24, 2002
- Report Date
- January 24, 2002
- Manufacturer
- PERCLOSE, INC.
- Product Code
- MGB
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE OPERATOR CLOSED THE ARTERIOTOMY WITH THE CLOSE 6 S DEVICE FOLLOWING A DIAGNOSTIC PROCEDURE. THE OPERATOR PLACED THE SUTURE TRIMMER ON THE SUTURES TO ADVANCE THE KNOT AND CUT THE SUTURE. THE SUTURE DID NOT CUT. WHEN THE OPERATOR REMOVED THE TRIMMER FROM THE GROIN, THEY NOTICED THAT THE MOST DISTAL BLACK TIP WAS MISSING. A VASCULAR SURGEON WAS CONSULTED WHO ADVISED AGAINST RETRIEVAL. NO FURTHER INJURY TO THE PATIENT OCCURRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SUTURE TRIMMER KP+T | KNOT PUSHER WITH SUTURE TRIMMER | MGB | PERCLOSE, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Other |