InjuryFKA

HYDROSTATIC BALLOON DILATOR

Received May 2, 1996 · Event occurred Feb 29, 1996

Report MW1009001 · MDR key 32515

Device

Generic name

Vessel Dilator

Manufacturer

Boston Scientific Corp.

Product problems

Fluid/Blood Leak

Patient

NO INFO

Extravasation

Narrative

Description of Event or Problem

DURING THE BALLOON DILATION PHASE OF ERCP, THERE WAS A SUDDEN LEAK IN THE BALLOON WITH EXTRAVASATION OF STERILE SALINE INTO THE DORSAL DUCT. PT DEVELOPED ACUTE PANCREATITIS.