MalfunctionPID
RIGIFLEX II
Received Jan 25, 2023 · Event occurred Dec 30, 2022
Report 3005099803-2023-00199 · MDR key 16243705
Device
Generic name
Dilator, Esophageal
Manufacturer
Boston Scientific CorporationModel number
M00554500Catalog number
5450
Lot number
C311372
Product problems
- Break
- Break
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RIGIFLEX II DILATATION BALLOON WAS USED IN THE ESOPHAGUS DURING AN ESOPHAGEAL DILATION PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE FOR TEST PERIOD, THE STAFF OPENED THE PACKAGED AND NOTICED THAT THE CATHETER WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE FIXED WIRE DILATATION BALLOON DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Additional Manufacturer Narrative
(B)(4).