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

Model Number	M00558420
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block a2: patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Block h6: imdrf device code a0402 captures the reportable event of balloon burst.
Event or Problem Description
It was reported to boston scientific corporation that a cre wireguided dilatation balloon was attempted to be used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure for a stone performed on 17 may 2026.During the procedure, the balloon ruptured after reaching a diameter of 13.5mm.No piece of balloon detached inside the patient.The procedure was completed with another of the same device.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 stable.

• 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: 25520931
• Report Number: 3005099803-2026-02476
• Device Sequence Number: 9940226
• Product Code: FDF
• UDI-Device Identifier: 08714729339359
• UDI-Public: (01)08714729339359(17)271119(10)35527277
• 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,Followup
• Report Date (Section B): 07/21/2026

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: M00558420
• Device Catalogue Number: M00558420
• Device Lot Number: 0035527277
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2026
• Supplement Date Received by Manufacturer: 06/29/2026
• Initial Report FDA Received Date: 06/16/2026
• Supplement Report FDA Received Date: 07/21/2026
• Date Device Manufactured: 12/19/2024
• 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 Sex: Male