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	04/29/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a cre pro wireguided dase dilatation balloon was attempted to be used in a procedure performed on (b)(6) 2026.During the procedure, a balloon leakage on the initial fluid was noticed.The anatomy location of the procedure is unknown and is being reported as it may have occurred in the esophagus.The procedure was completed with a different device.No further information has been obtained despite good faith efforts.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 stable.
Additional Manufacturer Narrative
Block h6: imdrf device code a0504 captures the reportable event of balloon leak in an unknown anatomy location.Block h11: investigation results.The device was not returned for analysis; therefore, a technical analysis could not be performed.With all available information, boston scientific concludes the reported event of balloon leak could not be confirmed.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause not established.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.

• 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: 25316917
• Report Number: 3005099803-2026-02171
• Device Sequence Number: 13241807
• Product Code: FGE
• UDI-Device Identifier: 08714729797593
• UDI-Public: (01)08714729797593(17)280928(10)37569669
• Combination Product (Y/N): N
• Initial Reporter Country: TD
• PMA/510(K) Number: K112994
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2026

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: 0037569669
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/16/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2026
• Supplement Date Received by Manufacturer: 07/13/2026
• Initial Report FDA Received Date: 05/28/2026
• Supplement Report FDA Received Date: 08/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/29/2025
• 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