MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RIGIFLEX II; DILATOR, ESOPHAGEAL

Model Number	M00554510
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Perforation (2001); No Code Available (3191)
Date of Event	12/13/2019
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
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.

• Brand Name: RIGIFLEX II
• Common Device Name: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9564068
• Report Number: 3005099803-2019-06443
• Device Sequence Number: 2936981
• Product Code: PID
• UDI-Device Identifier: 08714729719113
• UDI-Public: 08714729719113
• Combination Product (Y/N): N
• PMA/510(K) Number: K050232
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/13/2020
• Device Model Number: M00554510
• Device Catalogue Number: 5451
• Device Lot Number: C021175
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/13/2019
• Initial Report FDA Received Date: 01/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1