MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CRE PRO; Catheter, Biliary, Diagnostic

Model Number	M00558710
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0504 captures the reportable event of balloon leak in the esophagus.
Event or Problem Description
Note: this report pertains to one of two devices that were used in the same patient and procedure.It was reported to boston scientific corporation that an cre pro wireguided dase dilatation balloon was attempted to be used in the esophagus during a gastroscopy with dilatation procedure for esophageal stricture performed on (b)(6) 2026.During procedure, after the balloon was introduced through the working channel, the first two dilation stages (18mm and 19mm) were performed without any difficulties.During the third dilation stage (20 mm), the balloon was no longer able to maintain the fluid due to a possible leak in the device.The balloon was removed and a second of the same balloon device was attempted to be used.However, the same problem occurred with the second balloon.The procedure was completed successfully with a third cre pro wireguided dase dilatation balloon.The patient remained stable throughout the entire procedure and there were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fully recovered.

• Brand Name: CRE PRO
• Common Device Name: Catheter, Biliary, Diagnostic
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): Boston Scientific Cork Limited; cork business technology park; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; +1(914)571-6918
• MDR Report Key: 25767011
• Report Number: 3005099803-2026-02733
• Device Sequence Number: 9741035
• Product Code: FGE
• UDI-Device Identifier: 08714729797593
• UDI-Public: (01)08714729797593(17)280324(10)36146585
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K112994
• 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): 07/30/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M00558710
• Device Catalogue Number: M00558710
• Device Lot Number: 0036146585
• 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: 06/11/2026
• Supplement Date Received by Manufacturer: 07/10/2026
• Initial Report FDA Received Date: 07/09/2026
• Supplement Report FDA Received Date: 07/30/2026
• Date Device Manufactured: 03/25/2025
• 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
• Patient Sex: Unknown