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

Model Number	M00558420
Medical Device Problem Codes	Material Puncture/Hole (1504); Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2025
Type of Reportable Event	Malfunction
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 e1: initial reporters facility name is (b)(6) university; reported here as the facility name exceeded the character limit for the designated field.Block h6: imdrf device code a0414 captures the reportable investigation result of a balloon torn circumferential.Block h11: investigation results the returned cre wireguided dilatation balloon was analyzed, and a visual and microscopic evaluation found the balloon circumferentially torn.No other problems with the device were noted.The returned device revealed the balloon had a circumferential tear.It was reported that the balloon was pre-inflated before use in the patient; however, the ifu clearly states precaution: do not pre-inflate, pretest balloon, or attempt to refold balloon into protective sleeve.Testing or pre-inflating the balloon previously can lead the balloon to lose its original shape causing resistance when inserting it into the scope and it can cause the circumferential tear found on the balloon.Therefore, the most probable root cause is failure to follow instructions.
Event or Problem Description
It was reported to boston scientific corporation that a cre wireguided dilatation balloon was used in the duodenal papilla during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, water leaked during dilation.It was reported that the balloon had a hole.The procedure was completed with the original device.There were no patient complications reported as a result of this event.The patient's condition after the procedure was reported to be stable.Note: the instructions for use (ifu) indicate that this balloon should not be pre-inflated before use in the procedure.However, the customer reported that the balloon was pre-inflated before use in the patient.This event has been deemed a reportable event based on the investigation finding of a balloon circumferential tear.Please see block h11 for full investigation details.

• 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: 22484512
• Report Number: 3005099803-2025-03232
• Device Sequence Number: 18281491
• Product Code: FDF
• UDI-Device Identifier: 08714729339359
• UDI-Public: (01)08714729339359(17)260325(10)31495543
• 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): 07/11/2025

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 Expiration Date: 03/25/2026
• Device Model Number: M00558420
• Device Catalogue Number: M00558420
• Device Lot Number: 0031495543
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2025
• Initial Report FDA Received Date: 07/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2023
• 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: 67 YR
• Patient Sex: Male
• Patient Weight: 69 KG