MalfunctionDWZ
7FR SINGLE-USE ENDOMYOCARDIAL BIOPSY
Received Mar 9, 2005 · Event occurred Jan 21, 2005
Report 584669 · MDR key 584669
Device
Generic name
7fr Single-use Endomyocardial Biopsy
Manufacturer
Atc TechnologiesModel number
5030Catalog number
UNKNOWN
Lot number
UNK
Product problems
- Handpiece break
- Replace
Patient
*
- Therapy/non-surgical treatment/delayed/prolonged
Narrative
Description of Event or Problem
WHILE PERFORMING RIGHT HEART CATHETERIZATION WITH BIOPSY, FORCEPS FAILED. IT APPEARS THE HANDLE MECHANISM BROKE. IT WAS REPLACED WITH SIMILAR DEVICE AND PROCEDURE COMPLETED UNEVENTFULLY.