MalfunctionDWZ

BYCEP PC "7"

Received May 19, 1998 · Event occurred May 13, 1998

Report MW1013876 · MDR key 170123

Device

Generic name

Biopsy Forceps-disposable

Manufacturer

Boston Scientific Corp.

Model number

Catalog number

REL #6251

Lot number

606086

Product problems

Other (for use when an appropriate device code cannot be identified)

Patient

59 YR

Dural Tear
Arrhythmia
Device induced

Narrative

Description of Event or Problem

BIOPSY FORCEPS USED DURING RIGHT HEART CATHETERIZATION WITH BIOPSY, TORE TISSUE INSTEAD OF CUTTING. 10 TIMES USUAL AMOUNT TAKEN. PT HAD HEART ARRYTHMIAS AND HAD TO BE MEDICATED.