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

Model Number	M00554520
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	02/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that a rigiflex ii dilatation balloon was used in the esophagus during an esophageal dilatation procedure to treat achalasia performed on (b)(6) 2026.During the procedure, following dilatation, the physician advanced the scope into the esophagus and observed an esophageal perforation of about 2 to 3 cm in size.Multiple mantis clips were placed, successfully closing the perforation, and a fully covered stent was deployed.The physician stated that the perforation was not related to a device problem.The procedure was completed using the original rigiflex ii dilatation balloon.The patient condition following the procedure was unknown.
Additional Manufacturer Narrative
Block h6: imdrf patient code e2114 captures the reportable event of perforation.
Event or Problem Description
It was reported to boston scientific corporation that a rigiflex ii dilatation balloon was used in the esophagus during an esophageal dilatation procedure to treat achalasia performed on (b)(6) 2026.During the procedure, following dilatation, the physician advanced the scope into the esophagus and observed an esophageal perforation.Multiple mantis clips were placed, successfully closing the perforation, and a fully covered stent was deployed.The physician stated that the perforation was not related to a device problem.The procedure was completed using the original rigiflex ii dilatation balloon.The patient condition following the procedure was unknown.
Additional Manufacturer Narrative
Block h6: imdrf patient code e2114 captures the reportable event of perforation.Imdrf impact code f2301 captures the reportable event of additional device required (mantis clips, stent) to close and cover the perforation.Imdrf impact code f23 captures the reportable event of unexpected medical intervention.Block h11: investigation results: the device was not returned for analysis and was reported to be disposed; therefore, a technical analysis could not be performed.With all the available information, boston scientific concludes that the reported event of perforation could not be confirmed.The device was not returned for analysis because it was disposed.Without analysis of the actual device, there is a lack of objective evidence, or descriptive conditions of the event required to determine a probable root cause of the event.A review of the device history record (dhr) was performed.The review of the dhr identified that there were no process related non-conformances, scrap, or rework performed during the production that could explain the event.The reviews ensure each device meets specification prior to release for use.There is no indication the device manufacturing process contributed to the reported complaint.Review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.A risk review was completed and confirmed that the event of perforation, additional device required and unexpected device intervention were defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause not established.

• Brand Name: RIGIFLEX II
• Common Device Name: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): CREGANNA MEDICAL S R L; metro free trade zone; building 3 c; heredia 40101 ; CS 40101
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 24618262
• Report Number: 3005099803-2026-00970
• Device Sequence Number: 9585742
• Product Code: PID
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K050232
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2026

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: 09/23/2026
• Device Model Number: M00554520
• Device Catalogue Number: M00554520
• Device Lot Number: C346622
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2026
• Supplement Date Received by Manufacturer: 05/28/2026
• Initial Report FDA Received Date: 03/17/2026
• Supplement Report FDA Received Date: 06/18/2026
• Date Device Manufactured: 09/23/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown