FDA Adverse Event
Injury
Summary report: N
INTRACLUDE AORTIC DEVICE
MDR report key: 2884168
·
Received December 21, 2012
Report
- Report Number
- 3008500478-2012-00351
- Event Type
- Injury
- Date Received
- December 21, 2012
- Date of Event
- December 7, 2012
- Report Date
- December 7, 2012
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- DXC
- PMA / PMN Number
- K113182
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS DISCARDED BY THE HOSPITAL. THE PRODUCT WAS NOT RETURNED AND THE ROOT CAUSE COULD NOT BE DETERMINED FOR THIS DEVICE. THEREFORE A CAPA WAS NOT INITIATED FOR THIS EVENT. THIS INFORMATION WILL BE INCLUDED IN TRENDING AND FUTURE CAPA DETERMINATIONS.
Description of Event or Problem · 1
IT WAS REPORTED BY THE SALES REP THAT POST ROBOTIC MVR, UTILIZING THE ENDORETURN CANNULA AND THE INTRACLUDE AORTIC DEVICE, ICF100; THE PATIENT PRESENTED WITH COMPARTMENT SYNDROME TO THE LOWER EXTREMITY AND REQUIRED A FASCIOTOMY. THE DEVICE WAS NOT RETAINED BY THE CUSTOMER FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTRACLUDE AORTIC DEVICE | CLAMP, VASCULAR | DXC | EDWARDS LIFESCIENCES | ICF100 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |