MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CRE WIREGUIDED; DILATOR, ESOPHAGEAL

Model Number	M00558500
Medical Device Problem Codes	Inflation Problem (1310); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a041001 captures the reportable event of balloon pinhole in the esophagus.
Event or Problem Description
It was reported to boston scientific corporation that a cre wireguided dilatation balloon was used in the esophagus during an esophagogastroduodenoscopy (egd) procedure to treat stricture performed on (b)(6) 2026.During the procedure, when inflation was attempted inside the patient, the balloon would not inflate due to a pinhole that produces leak.The procedure was completed with another of the same device.There were no patient complications reported due to this event and the patient's condition at the conclusion of the procedure was reported to be fully recovered.

• Brand Name: CRE WIREGUIDED
• 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 ; 9145716918
• MDR Report Key: 25129000
• Report Number: 3005099803-2026-01694
• Device Sequence Number: 15604962
• Product Code: KNQ
• UDI-Device Identifier: 08714729339434
• UDI-Public: (01)08714729339434(17)281027(10)38063250
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2026

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: M00558500
• Device Catalogue Number: M00558500
• Device Lot Number: 0038063250
• 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: 04/17/2026
• Supplement Date Received by Manufacturer: 05/29/2026
• Initial Report FDA Received Date: 05/08/2026
• Supplement Report FDA Received Date: 06/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/27/2025
• 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