FDA Adverse Event
Malfunction
Summary report: N
SCANLAN VASCULAR TUNNELING SYSTEM
MDR report key: 5117859
·
Received September 18, 2015
Report
- Report Number
- 2126670-2015-00002
- Event Type
- Malfunction
- Date Received
- September 18, 2015
- Date of Event
- August 19, 2015
- Report Date
- September 17, 2015
- Manufacturer
- SCANLAN INTERNATIONAL, INC.
- Product Code
- DWS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SCANLAN INTERNATIONAL, INC. HAS MADE NUMEROUS ATTEMPTS TO OBTAIN FURTHER INFORMATION. NO ADDITIONAL INFORMATION IS AVAILABLE.
Description of Event or Problem · 1
DURING A VASCULAR TUNNELING PROCEDURE, THE BULLET TIP OF THE TUNNELING SHEATH CAME OFF AND WAS ALMOST LOST IN THE PATIENT. THE SURGEON RETRIEVED THE BULLET TIP WITH THE TUNNELING INSTRUMENT BEING USED IN THE PROCEDURE. NO IMPACT TO THE PATIENT. DEVICE DISCARDED. AS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 619365 | SCANLAN VASCULAR TUNNELING SYSTEM | DWS | SCANLAN INTERNATIONAL, INC. | 9009-18 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |