RIGIFLEX II
Received Jun 17, 2022 · Event occurred May 24, 2022
Report 3005099803-2022-03321 · MDR key 14738865
Device
Generic name
Dilator, Esophageal
Manufacturer
Boston Scientific CorporationModel number
M00554500Catalog number
5450
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Unknown
- Perforation
- Perforation
Narrative
Additional Manufacturer Narrative
THE COMPLAINANT WAS UNABLE TO REPORT THE LOT NUMBER; THEREFORE, THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. (B)(4). THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH 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 ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2022. AFTER THE PROCEDURE, WHEN THE PHYSICIAN LOOKED IN THE ESOPHAGUS POST DILATION, PERFORATION WAS NOTICED. ENDOSCOPIC CLOSURE WAS ATTEMPTED BUT A SURGICAL INTERVENTION WAS NEEDED. SURGERY WAS SUCCESSFUL; HOWEVER, THE PATIENT WAS ADMITTED TO THE HOSPITAL BEYOND THE STANDARD OF CARE. THERE WAS NO ALLEGED PROBLEM WITH THE BALLOON. THE PATIENT CONDITION FOLLOWING THE INTERVENTION WAS REPORTED TO BE STABLE.