MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CRE PRO; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M00558610
Medical Device Problem Codes	Inflation Problem (1310); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1: this event was reported by the sales representative.The healthcare facility is: (b)(6).Block h6: imdrf device code a0414 captures the reportable investigation result of a balloon torn circumferential.Block h11: investigation results- the returned cre pro wireguided dilatation balloon was analyzed, and a visual and microscopic inspection found that the balloon was torn circumferentially.No other problems with the device were noted.Investigation of the returned device revealed that the balloon was torn circumferentially.The circumferential tear on the balloon is likely to have occurred due to procedural factors such as excess of pressure or interaction with other devices.Also, it is possible that interaction with a sharp surface during or previous to the procedure could create friction on the balloon, causing the tear found on the balloon.Therefore, the most probable root cause is an adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that a cre pro wireguided dilatation balloon was used in the d2 duodenal during a papilla dilation procedure performed on (b)(6) 2025.During the procedure, the cre balloon could not be inflated.All connections and ports were thoroughly checked to ensure they were properly connected and sealed with no leaks, but the balloon still could not be inflated.The procedure was completed with another cre pro wireguided dilatation balloon.There were no patient complications reported as a result of this event.This event has been deemed a reportable event based on the investigation finding of a balloon circumferential tear.Please see block h11 for full investigation details.

• 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 22645839
• Report Number: 3005099803-2025-03561
• Device Sequence Number: 21032196
• Product Code: FGE
• UDI-Device Identifier: 08714729797494
• UDI-Public: (01)08714729797494(17)251224(10)30916256
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K112994
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/29/2025

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 Expiration Date: 12/24/2025
• Device Model Number: M00558610
• Device Catalogue Number: M00558610
• Device Lot Number: 0030916256
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/04/2025
• Initial Report FDA Received Date: 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2023
• 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