RIGIFLEX II
Received Sep 20, 2019 · Event occurred Aug 26, 2019
Report 3005099803-2019-04587 · MDR key 9097538
Device
Generic name
Dilator, Esophageal
Manufacturer
Boston Scientific CorporationModel number
M00554510Catalog number
5451
Lot number
C018209
Product problems
- Deflation Problem
- Deflation Problem
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
(B)(6). 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 ENDOSCOPY PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE BALLOON WAS INFLATED OUTSIDE THE PATIENT FOR INSPECTION; HOWEVER, THE BALLOON WOULD NOT FULLY DEFLATE. THE PROCEDURE WAS COMPLETED WITH ANOTHER RIGIFLEX II DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.