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

Model Number	M00558400
Medical Device Problem Codes	Burst Container or Vessel (1074); Leak/Splash (1354); Use of Device Problem (1670); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2025
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 common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat a common bile duct stone performed on (b)(6) 2025.During the procedure, when the dilatation balloon was used to dilate the stricture of the common bile duct, the balloon leaked gas without pressurization, and the balloon was damaged after examination.The procedure was completed with another cre wireguided dilatation balloon.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 d2b: the remaining pro codes (product codes) are fdt and knq; reported here as pro codes (product codes) exceeded the character limit for the designated field.Block h6: imdrf device code a04 captures the reportable event of balloon damage.
Additional Manufacturer Narrative
Block h2 (additional information): block a1 (patient identifier), b5 (describe event or problem), and h6 (deivce codes) have been updated.Block d2b: the remaining pro codes (product codes) are fdt and knq; reported here as pro codes (product codes) exceeded the character limit for the designated field.Block h6: imdrf device code a04 captures the reportable event of balloon damage.
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 to treat a common bile duct stone performed on (b)(6) 2025.During the procedure, when the dilatation balloon was used to dilate the stricture of the common bile duct, the balloon leaked gas without pressurization, and the balloon was damaged after examination.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.***additional information received august 5, 2025*** when using an expanding balloon to dilate the stenosis part of the common bile duct, the balloon began to leak before any pressure was applied.It was found that the balloon had already burst.

• 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 22709487
• Report Number: 3005099803-2025-03747
• Device Sequence Number: 12989639
• Product Code: FDF
• UDI-Device Identifier: 08714729339335
• UDI-Public: (01)08714729339335(17)270806(10)34782813
• 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): 08/28/2025

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: M00558400
• Device Catalogue Number: M00558400
• Device Lot Number: 0034782813
• 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: 07/11/2025
• Supplement Date Received by Manufacturer: 08/05/2025
• Initial Report FDA Received Date: 08/04/2025
• Supplement Report FDA Received Date: 08/28/2025
• Date Device Manufactured: 09/05/2024
• 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: 59 YR
• Patient Sex: Female