RIGIFLEX II
Received Jun 25, 2024 · Event occurred May 1, 2024
Report 3005099803-2024-02913 · MDR key 19607067
Device
Generic name
Dilator, Esophageal
Manufacturer
Boston Scientific CorporationProduct problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Perforation
- Perforation
Narrative
Additional Manufacturer Narrative
BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. BLOCK D4, H4: THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. BLOCK H6 PATIENT CODE E2114 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF PATIENT PERFORATION.
Description of Event or Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RIGIFLEX II DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE GOJ (GASTRO ESOPHAGEAL JUNCTION) DURING AN ACHALASIA DILATION PROCEDURE. THE EXACT PROCEDURE DATE WAS UNKNOWN. DURING THE PROCEDURE, THE PATIENT WAS BEING TREATED FOR ACHALASIA WITH A RIGIFLEX BALLOON WHICH HAD CAUSED A PERFORATION. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.