RIGIFLEX II
Received Aug 7, 2020 · Event occurred Jul 10, 2020
Report 3005099803-2020-03061 · MDR key 10379013
Device
Generic name
Dilator, Esophageal
Manufacturer
Boston Scientific CorporationModel number
M00554500Catalog number
5450
Lot number
C021826
Product problems
- Burst Container or Vessel
- Burst Container or Vessel
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
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 DURING AN ACHALASIA BALLOONING PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, IT WAS NOTED THAT 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.