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

Model Number	M00558410
Medical Device Problem Codes	Burst Container or Vessel (1074); Leak/Splash (1354); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0402 captures the reportable event of a 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 bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat an abdominal pain performed on (b)(6) 2025.During the procedure, the contrast medium was injected outside the body and liquid leakage was found.It was reported that the balloon burst at 10mm, but no piece of the balloon detached inside the patient.A photo of the complaint device outside the patient was provided and showed that the balloon was burst.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: 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.
Additional Manufacturer Narrative
Block h2 (correction): block b5 (describe event or problem) and block h6 (device codes) have been corrected.Block h6: imdrf device code a0402 captures the reportable event of a balloon burst.Block h11: investigation results the returned cre wireguided dilatation balloon was analyzed, and a visual inspection found no damages to the device.Functional inspection was performed, and the balloon was able to be inflated without any problem; however, it was not able to hold the pressure due to a pinhole in the balloon (which produces a leak), located approximately at 66 mm from the tip of the device.Microscopic inspection confirmed the balloon pinhole.Media analysis was performed based on the photo provided by the complainant and showed the device is observed deflated outside the patient anatomy; however, no damage is identified in the device.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of balloon burst was not confirmed.The pinhole problem found could have been interpreted by the customer as the reported event of a balloon burst.The pinhole found is likely to have occurred due to procedural factors such as excess of pressure, interaction with other devices, or anatomical conditions.Also, it is possible that interaction with a sharp surface during or previous to the procedure could have caused the problem found on the proximal section of 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 wireguided dilatation balloon was attempted to be used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat an abdominal pain performed on september 05, 2025.During the procedure, the contrast medium was injected outside the body and liquid leakage was found.It was reported that the balloon burst at 10mm, but no piece of the balloon detached inside the patient.A photo of the complaint device outside the patient was provided and showed that the balloon was burst.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: 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.***correction noted on november 26, 2025*** it was reported that the balloon leakage occurred inside the patient and the balloon was not pre-inflated prior to use in the patient.

• 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: 23184640
• Report Number: 3005099803-2025-04884
• Device Sequence Number: 18639898
• Product Code: FDF
• UDI-Device Identifier: 08714729339342
• UDI-Public: (01)08714729339342(17)261013(10)32838217
• 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): 12/22/2025

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: M00558410
• Device Catalogue Number: M00558410
• Device Lot Number: 0032838217
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2025
• Supplement Date Received by Manufacturer: 11/26/2025
• Initial Report FDA Received Date: 09/30/2025
• Supplement Report FDA Received Date: 12/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/13/2023
• 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 Age: 56 YR
• Patient Sex: Female
• Patient Weight: 65 KG