FDA Adverse Event
Malfunction
Summary report: N
SCANLAN VASCULAR TUNNELER SHEATH
MDR report key: 3221825
·
Received July 9, 2013
Report
- Report Number
- 2126670-2013-00003
- Event Type
- Malfunction
- Date Received
- July 9, 2013
- Date of Event
- June 11, 2013
- Report Date
- July 9, 2013
- Manufacturer
- SCANLAN INTERNATIONAL, INC.
- Product Code
- DWS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NO FURTHER INFO IS AVAILABLE TO SCANLAN INTERNATIONAL, INC. DEVICE DISPOSITION IS UNK.
Description of Event or Problem · 1
THE BULLET TIP OF THE TUNNELER SHEATH BECAME DISLODGED DURING A FEMOROPOPLITEAL PROCEDURE. SURGERY TIME WAS EXTENDED 2 HOURS TO LOCATE THE TIP AS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 314004 | SCANLAN VASCULAR TUNNELER SHEATH | VASCULAR TUNNELER SHEATH | DWS | SCANLAN INTERNATIONAL, INC. | 9009-18 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |