MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CRE Fixed Wire; dilator, esophageal

Model Number	M00558370
Medical Device Problem Codes	Difficult to Remove (1528); Material Twisted/Bent (2981); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a cre fixed wire dilatation balloon was attempted to be used in the esophagus during a gastrointestinal dilation procedure performed on (b)(6) 2026.During device removal following the completion of the procedure, the deflated balloon catheter became lodged at the distal end of the endoscope working channel and could not be withdrawn through the channel.The procedure was completed by removing the endoscope and balloon together.Subsequent bench testing was unable to remove the balloon from the endoscope.Upon inspection, the distal tip was bent and twisted.The procedure was completed with the original device.There were no patient complications reported as a result of this event and the patient condition following procedure was stable.
Additional Manufacturer Narrative
Block h6: imdrf device code a040609 captures the reportable event of balloon tip bent.Block h11: investigation results the returned cre fixed wire dilatation balloon was analyzed, and a visual examination found that the sheath deformed.Also, the tip section of the balloon was observed kinked.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of tip bent was confirmed.The analysis on the returned device found that the distal tip was found kinked, and the sheath section of the catheter was deformed.It is possible that the kink found in the distal tip and the sheath deformed occurred due to procedural factors such as excess of force or the manner as the device was handled and manipulated.Excessive manipulation of the device without enough care could have induced the distal tip kinked and the sheath deformed found.Therefore, the most probable root cause is an adverse event related to procedure.A review of the device history record (dhr) was performed.The review of the dhr identified that there were no process related non-conformances, scrap, or rework performed during the production that could explain the event.The reviews ensure each device meets specification prior to release for use.There is no indication the device manufacturing process contributed to the reported complaint.

• Brand Name: CRE Fixed Wire
• Common Device Name: dilator, esophageal
• 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 ; EI 01752 ; +1(914)571-6918
• MDR Report Key: 50425855
• Report Number: 3005099803-2026-03474
• Device Sequence Number: 9038492
• Product Code: KNQ
• UDI-Device Identifier: 08714729195993
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: Exempt
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/25/2026

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: M00558370
• Device Catalogue Number: M00558370
• Device Lot Number: 0039083886
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/11/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2026
• Initial Report FDA Received Date: 08/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/14/2026
• 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: Unknown