RIGIFLEX II
Received Jan 8, 2020 · Event occurred Dec 13, 2019
Report 3005099803-2019-06443 · MDR key 9564068
Device
Generic name
Dilator, Esophageal
Manufacturer
Boston Scientific CorporationModel number
M00554510Catalog number
5451
Lot number
C021175
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Perforation
- No Code Available
- Perforation
- No Code Available
Narrative
Additional Manufacturer Narrative
PATIENT'S EXACT AGE IS UNKNOWN; HOWEVER, IT WAS REPORTED THAT THE PATIENT WAS OVER THE AGE OF 18. (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 ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EDG) WITH DILATATION PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, AFTER THE DILATATION, IT WAS NOTED THAT THE ESOPHAGUS HAD BEEN PERFORATED. THE PATIENT WAS THEN TRANSFERRED TO (B)(6) WHERE AN EMERGENT SURGERY WAS PERFORMED BY A CARDIO-THORACIC SURGEON. FOLLOWING THE TREATMENT, THE PATIENT CONDITION WAS REPORTED TO BE STABLE. IT WAS NOTED THAT THERE WAS NO MALFUNCTION OF THE RIGIFLEX II DILATATION BALLOON, AND PER THE PHYSICIAN'S ASSESSMENT, THE CAUSE OF THE PERFORATION WAS THE ANATOMY. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.