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

Model Number	M00558710
Medical Device Problem Codes	Inflation Problem (1310); Leak/Splash (1354); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Note: this report pertains to one of three devices that were used in the same patient and procedure.It was reported to boston scientific corporation that a cre pro wireguided dase dilatation balloon was being prepared to be used in the esophagus during an esophagogastroduodenoscopy (egd) procedure for dilatation performed on (b)(6) 2026.During preparation, the balloon exhibited small bubbles and failed to fully inflate.Troubleshooting consisted of attempting to inflate two additional balloons from the same lot, but the same problem occurred.The procedure was completed with a fourth device of the same type.There were no patient complications reported as a result of this event.The patients condition at the conclusion of the procedure was reported to be fully recovered.Note: the instructions for use (ifu) indicate that this balloon should not be pre-inflated prior to use in the procedure.However, the customer reported that the balloon was pre-inflated outside of the patient.
Additional Manufacturer Narrative
Block h6: imdrf device code a0504 captures the reportable event of balloon leak in the esophagus.

• 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: 25587767
• Report Number: 3005099803-2026-02555
• Device Sequence Number: 12123226
• Product Code: FGE
• UDI-Device Identifier: 08714729797593
• UDI-Public: (01)08714729797593(17)280331(10)36202003
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K112994
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: 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: 0036202003
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/23/2026
• 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: 05/27/2026
• Supplement Date Received by Manufacturer: 07/06/2026
• Initial Report FDA Received Date: 06/22/2026
• Supplement Report FDA Received Date: 07/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2025
• 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