MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CRE WIREGUIDED; COLONOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number	M00558500
Medical Device Problem Codes	Inflation Problem (1310); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Note: this report pertains to one of two cre wireguided dilatation balloons used on the same patient during the same procedure.It was reported to boston scientific corporation that two cre wireguided dilatation balloons were attempted to be used in the esophagus during an esophagogastroduodenoscopy (egd) procedure for treatment of an esophageal stricture performed on an unknown date.During the procedure, the first cre wireguided dilatation balloon was inflated to 18mm (3atm) without problem and subsequently to 20mm (6atm) as intended.After repositioning, the balloon was reinflated to 20mm, at which time the clinician observed that the balloon began leaking and was unable to maintain pressure.The device was removed.A second cre wireguided dilatation balloon was then introduced and inflated to 20mm (6atm).Upon inflation, this balloon immediately leaked and similarly could not maintain pressure, requiring removal.The procedure was completed with another cre wireguided dilatation balloon.There were no patient complications reported as a result of this event.The patient condition following procedure was reported to have fully recovered.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: imdrf device code a0504 captures the reportable event of a balloon leak in the esophagus.

• Brand Name: CRE WIREGUIDED
• Common Device Name: COLONOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• 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: 24218007
• Report Number: 3005099803-2026-00360
• Device Sequence Number: 15794419
• Product Code: KNQ
• UDI-Device Identifier: 08714729339434
• UDI-Public: (01)08714729339434(17)280608(10)36930433
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/29/2026

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: 0036930433
• 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: 01/07/2026
• Initial Report FDA Received Date: 01/29/2026
• Date Device Manufactured: 07/09/2025
• 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