FDA Adverse Event
Injury
Summary report: N
GUIDELINER V2 CATHETER
MDR report key: 2792341
·
Received October 16, 2012
Report
- Report Number
- 2134812-2012-00043
- Event Type
- Injury
- Date Received
- October 16, 2012
- Date of Event
- September 20, 2012
- Report Date
- October 16, 2012
- Manufacturer
- VASCULAR SOLUTIONS, INC.
- Product Code
- DQY
- PMA / PMN Number
- K112082
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED TO MANUFACTURER.
Description of Event or Problem · 1
A GUIDELINER V2 CATHETER WAS BEING USED IN A CLINICAL PROCEDURE WHEN THE DISTAL TIP SEPARATED FROM THE REST OF THE CATHETER. THE PATIENT WAS SENT TO ANOTHER FACILITY WHERE THE DISTAL TIP WAS RETREIVED USING A SNARE; ALL PIECES WERE REMOVED WITHOUT FURTHER PATIENT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GUIDELINER V2 CATHETER | PERCUTANEOUS CATHETER | DQY | VASCULAR SOLUTIONS, INC. | 5571 | 558533 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |