RIGIFLEX II
Received Mar 11, 2021 · Event occurred Feb 17, 2021
Report 3005099803-2021-01024 · MDR key 11463652
Device
Generic name
Dilator, Esophageal
Manufacturer
Boston Scientific CorporationModel number
M00554500Catalog number
5450
Lot number
C025220
Product problems
- Burst Container or Vessel
- Burst Container or Vessel
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
(B)(4). ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED AND IS NOT AVAILABLE FOR RETURN. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.
Description of Event or Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RIGIFLEX II DILATATION BALLOON WAS USED IN THE COMMON BILE DUCT (CBD) DURING AN ACHALASIA PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE BALLOON BURST. THE PROCEDURE WAS COMPLETED WITH ANOTHER RIGIFLEX II DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.