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

Model Number	M00558400
Medical Device Problem Codes	Burst Container or Vessel (1074); Inflation Problem (1310); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1: the initial reporter facility name is affiliated (b)(6); reported here as the name exceeded character limit for designated field.Block h6: imdrf device code a0402 captures the reportable investigation result of balloon burst.Block h11: the returned cre wireguided dilatation balloon was analyzed, and a visual and microscopic evaluation found that the device was ruptured which makes the device failed to inflate.No other problems with the device were noted.The product analysis revealed that the balloon was ruptured which makes the device failed to inflate.The balloon was pre inflated prior to use.However, the ifu clearly states "precaution: do not pre-inflate, pretest balloon, or attempt to refold balloon into protective sleeve." testing the balloon previously can cause the balloon to lose its original shape causing resistance when inserting it into the scope and can cause the rupture found on the balloon.Based on all gathered information, the most probable root cause is failure to follow instructions.A labeling review was performed and, from the information available, this device was not used per the instructions for use (ifu) / product label.
Event or Problem Description
It was reported to boston scientific corporation that a cre wireguided dilatation balloon was used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat bile duct stones performed on (b)(6) 2025.During the procedure, the balloon could not be dilated, and the dilation effect was not achieved.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event and the patient's condition at the conclusion of the procedure was reported to be stable.Note: the instructions for use (ifu) indicate that this balloon should not be pre-inflated prior to use in the procedure.However, the customer reported that the balloon was pre-inflated outside of the patient.This event has been deemed a reportable event based on the investigation finding of device balloon burst.Please see block h11 for full investigation details.

• Brand Name: CRE WIREGUIDED
• Common Device Name: DUODENOSCOPE 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: 23459088
• Report Number: 3005099803-2025-05642
• Device Sequence Number: 7969183
• Product Code: FDT
• UDI-Device Identifier: 08714729339335
• UDI-Public: (01)08714729339335(17)270701(10)34542549
• 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): 11/03/2025

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: 0034542549
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2025
• Initial Report FDA Received Date: 11/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2024
• 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: 45 YR
• Patient Sex: Female
• Patient Weight: 63 KG