inforMED
MalfunctionDWZ

ENDOMYOCARDIAL BIOPSY FORCEPS

Received May 9, 2010 · Event occurred Feb 23, 2010

Report 1700213 · MDR key 1700213

Device

Generic name

Endomyocardial Biopsy Forceps

Model number

*

Catalog number

C22113

Lot number

01418531

Product problems

  • Failure to Obtain Sample

Patient

42 YR

  • No Consequences Or Impact To Patient

Narrative

Description of Event or Problem

BIOPTOME CATHETER FORCEPS FAILED TO OBTAIN AN ENDOMYOCARDIAL BIOPSY SAMPLE. A SECOND BIOPTOME CATHETER WAS USED WHICH WORKED PERFECTLY. THE PATIENT HAD NO COMPLICATIONS DURING THIS PROCEDURE.