FDA Adverse Event
Injury
Summary report: N
CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING HANDLE
MDR report key: 1202983
·
Received October 16, 2008
Report
- Report Number
- 6000002-2008-08942
- Event Type
- Injury
- Date Received
- October 16, 2008
- Date of Event
- October 10, 2008
- Report Date
- October 10, 2008
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- KRH
- PMA / PMN Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED.
Description of Event or Problem · 1
UPPER PART OF THE HANDLE BROKE OFF DURING IMPLANTATION OF A PHYSIO RING FOR A PORT ACCESS ISOLATED MITRAL VALVE RECONSTRUCTION. WHEN SURGEON INTRODUCED RING THROUGH WORKING PORT AND WHILE HE WAS BRINGING IT IN PLACE, THEY HEARD A CRACK AND THE HANDLE CAME LOOSE FROM THE HOLDER. AFTER INSPECTION OF THE HOLDER, IT WAS NOTICED THAT THE UPPER PART OF THE HANDLE HAD BROKEN OFF. THE MISSING PIECE COULD NOT BE LOCATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING HANDLE | ANNULOPLASTY RING HANDLE | KRH | EDWARDS LIFESCIENCES | 1150 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Hospitalization| R |