MalfunctionKNQ
CRE
Received Feb 17, 2015 · Event occurred Feb 4, 2015
Report 4593512 · MDR key 4593512
Device
Generic name
Esophageal Balloon Dilation Catheter
Model number
M00558380Catalog number
M00558380
Lot number
17499541
Product problems
- Sticking
Patient
72 YR
- No Information
Narrative
Description of Event or Problem
CRE DISPOSABLE BALLOON DILATOR WAS STUCK IN ESOPHAGOGASTRODUODENOSCOPY (EGD) SCOPE AND COULD NOT BE REMOVED BY PHYSICIAN DURING EGD PROCEDURE. THE BALLOON WAS DEFLATED, AND THE SCOPE WAS NOT TORQUED HOWEVER THE BALLOON COULD NOT BE PULLED OUT OR ADVANCED IN EGD SCOPE. THE SCOPE WAS REMOVED, BALLOON CUT AND REMOVED FROM SCOPE. THE DILATOR AND PACKAGING WAS GIVEN TO THE ENDOSCOPY CLINICAL PARTNER.