MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CRE WIREGUIDED; COLONOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number	M00558420
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	10/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a cre wireguided dilatation balloon was attempted to be used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat bile duct dilatation with calculi performed on (b)(6) 2025.During the procedure, the nurse placed the cre balloon at the papilla and dilated it with the pressure handle, but the liquid could not enter the balloon.The balloon could not be opened after repeated operations.The procedure was completed with another cre wireguided dilatation balloon.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.Note: this event has been deemed a reportable event based on the investigation finding of a balloon longitudinally torn.Please see block h11 for full investigation details.
Additional Manufacturer Narrative
Block h6: imdrf device code a0414 captures the reportable investigation result of balloon longitudinally torn.Block h11: investigation results the returned cre wireguided dilatation balloon was analyzed, and a visual and microscopic inspection found that the balloon had a longitudinal tear.No other problems with the device were noted.The results of the analysis performed on the returned device found that the balloon had a longitudinal tear.The longitudinal tear found 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 have caused the problem found on the balloon.Therefore, the most probable root cause is an adverse event related to procedure.

• Brand Name: CRE WIREGUIDED
• Common Device Name: COLONOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• 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 ; 9145716918
• MDR Report Key: 23914423
• Report Number: 3005099803-2025-06918
• Device Sequence Number: 9148172
• Product Code: FDF
• UDI-Device Identifier: 08714729339359
• UDI-Public: (01)08714729339359(17)270702(10)34555959
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K110833
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/29/2025

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 Model Number: M00558420
• Device Catalogue Number: M00558420
• Device Lot Number: 0034555959
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2025
• Initial Report FDA Received Date: 12/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2024
• 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 Age: 74 YR
• Patient Sex: Female
• Patient Weight: 45 KG