MalfunctionKNQ
CRE FIXED WIRE ESOPHAGEAL BALLOON DILATATION CATHETER
Received Aug 15, 2022
Report MW5111484 · MDR key 15233649
Device
Generic name
Dilator, Esophageal
Manufacturer
Boston Scientific LimitedCatalog number
REF M00558380
Lot number
29026888
Product problems
- Failure to Advance
- Mechanical Jam
Patient
Unknown
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
DR. WAS TRYING TO DO A BALLOON DILATATION DURING AN EGD, HOWEVER WHEN FEEDING THE BALLOON THROUGH THE SCOPE'S CHANNEL, IT WOULD NOT GO THROUGH, IT KEEPS GETTING STUCK. TRIED TO CHANGE SCOPES BUT IT WAS STILL GETTING STUCK. WE CHANGED THE BALLOON, AND IT FINALLY WENT THROUGH. FDA SAFETY REPORT ID #(B)(4).