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

Model Number	M00558380
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a cre fixed wire dilatation balloon was used during an upper endoscopy procedure performed on (b)(6) 2026.It was reported that after dilation, the balloon would not deflate all way down to remove the balloon from the endoscope.The procedure was completed with another of the same device.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 h6: imdrf device code a140101 captures the reportable event of balloon failure to deflate.Block h11: investigation results the returned cre fixed wire dilatation balloon was analyzed, visual and microscopic inspection found that the balloon was detached with a mechanical cut in the inner wire.Also, the distal part with the tip of the balloon and part of the wire were not returned for analysis.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of balloon failure to deflate was not confirmed.The device was returned with the balloon detached and the inner wire with a partially separated section.It is possible that the balloon could not be pulled out of the scope, and the physician had to cut the catheter.It's important to mention that there is evidence of a mechanical cut on the wire and the balloon.Based on all gathered information and the analysis performed, the most probable cause of this complaint is cause not established.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.A similar complaint review was completed.There were no emerging trends identified that warrant further action.

• 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 ; +1(914)571-6918
• MDR Report Key: 50255895
• Report Number: 3005099803-2026-03336
• Device Sequence Number: 10125488
• Product Code: KNQ
• UDI-Device Identifier: 08714729202011
• UDI-Public: (01)08714729202011(17)280129(10)38472803
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: Exempt
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2026

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: M00558380
• Device Catalogue Number: M00558380
• Device Lot Number: 0038472803
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/06/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2026
• Supplement Date Received by Manufacturer: 08/17/2026
• Initial Report FDA Received Date: 08/14/2026
• Supplement Report FDA Received Date: 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/29/2026
• 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