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

Model Number	M00558440
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2025
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 h6: imdrf device code a0504 captures the reportable event of a balloon leak in the esophagus.
Event or Problem Description
It was reported to boston scientific corporation that a cre wireguided dilatation balloon was attempted to be used in the esophagus during a gastroscopy with esophageal dilatation procedure to treat a benign stricture performed on (b)(6) 2025.During the procedure, the balloon presented a leak while inflated.No further information has been obtained despite good-faith efforts.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that a cre wireguided dilatation balloon was attempted to be used in the esophagus during a gastroscopy with esophageal dilatation procedure to treat a benign stricture performed on (b)(6) 2025.During the procedure, the balloon presented a leak while inflated.No further information has been obtained despite good-faith efforts.There were no patient complications reported as a result of this event.**additional information received on september 3, 2025** it was reported that the procedure was completed with another of the same device.
Additional Manufacturer Narrative
Block h2 (additional information): block b5 (describe event or problem) has been updated.Block h6: imdrf device code a0504 captures the reportable event of a balloon leak in the esophagus.

• 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 22919895
• Report Number: 3005099803-2025-04336
• Device Sequence Number: 16008210
• Product Code: KNQ
• UDI-Device Identifier: 08714729339373
• UDI-Public: (01)08714729339373(17)270625(10)34511788
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2025

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 Model Number: M00558440
• Device Catalogue Number: M00558440
• Device Lot Number: 0034511788
• 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: 08/07/2025
• Supplement Date Received by Manufacturer: 09/03/2025
• Initial Report FDA Received Date: 08/28/2025
• Supplement Report FDA Received Date: 09/19/2025
• Date Device Manufactured: 07/25/2024
• 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