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

Model Number	M00558380
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2026
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 an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2026.During the procedure, the balloon leaked and a pinhole was noticed.The procedure was completed with another cre fixed wire dilatation balloon.There were no patient complications reported as a result of this event.The patients condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block h6: imdrf device code a041001 captures the reportable event of balloon pinhole in the esophagus.

• 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: 50256063
• Report Number: 3005099803-2026-03340
• Device Sequence Number: 10135065
• Product Code: KNQ
• UDI-Device Identifier: 08714729202011
• UDI-Public: (01)08714729202011(17)280427(10)39205585
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 09/11/2026

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: 0039205585
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2026
• Supplement Date Received by Manufacturer: 08/20/2026
• Initial Report FDA Received Date: 08/14/2026
• Supplement Report FDA Received Date: 09/11/2026
• Date Device Manufactured: 04/28/2026
• 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