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	11/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0504 captures the reportable event of 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 during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2025.During the procedure, it was reported that a leak was noted on multiple spots at the shoulder of the balloon.The procedure was completed with another of the same device.No further information has been obtained despite good faith efforts.The anatomy location is unknown and is being reported as the leak may have occurred in the esophagus.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 during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2025.During the procedure, it was reported that a leak was noted on multiple spots at the shoulder of the balloon.The procedure was completed with another of the same device.No further information has been obtained despite good faith efforts.The anatomy location is unknown and is being reported as the leak may have occurred in the esophagus.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0504 captures the reportable event of balloon leak in the esophagus.Block h11: investigation results: the returned cre wireguided dilatation balloon was analyzed, and a visual evaluation noted no damages to the device.Functional inspection was performed and found that the balloon was not able to hold pressure due to a pinhole located approximately at 90 mm from the tip of the device which produces a leak.Microscopic inspection also found evidence of a pinhole.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of balloon leak was confirmed.The returned balloon was found to have a pinhole located approximately at 90 mm from the tip of the device which produces a leak.The problem found could have been generated due to procedural factors such as excess of pressure, interaction with other devices, or anatomical conditions.Also, it is possible that there was an interaction with a sharp surface during or previous the procedure.Therefore, the most probable root cause is an adverse event related to procedure.

• 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: 23722600
• Report Number: 3005099803-2025-06410
• Device Sequence Number: 10464860
• Product Code: KNQ
• UDI-Device Identifier: 08714729339373
• UDI-Public: (01)08714729339373(17)280715(10)37220152
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2026

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: M00558440
• Device Catalogue Number: M00558440
• Device Lot Number: 0037220152
• 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: 11/13/2025
• Supplement Date Received by Manufacturer: 01/12/2026
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 01/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2025
• 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