FDA Adverse Event
Malfunction
Summary report: N
MOBICATH STEERABLE SHEATH
MDR report key: 4113651
·
Received September 17, 2014
Report
- Report Number
- 2183787-2014-00109
- Event Type
- Malfunction
- Date Received
- September 17, 2014
- Date of Event
- August 22, 2014
- Report Date
- August 27, 2014
- Manufacturer
- GREATBATCH MEDICAL
- Product Code
- DYB
- PMA / PMN Number
- K130559
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
NA.
Description of Event or Problem · 1
IT WAS OBSERVED THAT THERE WAS BLOOD FLOWBACK FROM THE VALVE OF THE MOBICATH SHEATH WHEN A CATHETER WAS INSERTED. THE CATHETER WAS REMOVED AND IT WAS FOUND THAT THE VALVE WAS INSIDE AND NOT CLOSED COMPLETELY. THE ISSUE WAS RESOLVED BY CHANGING THE SHEATH TO ANOTHER ONE. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT CONSEQUENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 576082 | MOBICATH STEERABLE SHEATH | STEERABLE SHEATH | DYB | GREATBATCH MEDICAL | 1000182-001 | W2704003 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |