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

Model Number	M00558500
Medical Device Problem Codes	Burst Container or Vessel (1074); Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2026
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) with dilatation procedure to treat a stricture performed on (b)(6) 2026.During the procedure, the balloon was able to be inflated to 19 mm; however, when it was inflated to 20 mm, the balloon could not be inflated.It was reported that the balloon popped and no pieces of the balloon detached inside the patient.The procedure was completed with another cre fixed wire dilatation balloon.There were no patient complications reported as a result of this event and the patient condition following procedure was reported to have fully recovered.
Additional Manufacturer Narrative
Block h6: imdrf device code a0402 captures the reportable event of a balloon burst.
Additional Manufacturer Narrative
Block h6: imdrf device code a0402 captures the reportable event of a balloon burst.Block h11: investigation results.The returned cre wireguided dilatation balloon was analyzed, and a visual examination found that the device was longitudinally torn.Microscopic inspection was performed, and the balloon was longitudinally torn.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of balloon burst was not confirmed.The analysis on the returned device found that the balloon had a longitudinally torn.It is possible that the burst occurred due to procedural factors encountered during the procedure or it can be due to excess pressure.Also, it is possible that interaction with any kind of a sharp surface during or previous to the procedure could create friction on the balloon and could have caused the balloon burst.These factors and interactions could influence the damage found in the balloon.Therefore, the most probable root cause is adverse event related to procedure.Device history records review: it was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.
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) with dilatation procedure to treat a stricture performed on (b)(6) 2026.During the procedure, the balloon was able to be inflated to 19 mm; however, when it was inflated to 20 mm, the balloon could not be inflated.It was reported that the balloon popped and no pieces of the balloon detached inside the patient.The procedure was completed with another cre fixed wire dilatation balloon.There were no patient complications reported as a result of this event and the patient condition following procedure was reported to have fully recovered.

• 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: 24331961
• Report Number: 3005099803-2026-00580
• Device Sequence Number: 13204850
• Product Code: KNQ
• UDI-Device Identifier: 08714729339434
• UDI-Public: (01)08714729339434(17)280603(10)36893824
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2026

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: M00558500
• Device Catalogue Number: M00558500
• Device Lot Number: 0036893824
• 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: 01/19/2026
• Supplement Date Received by Manufacturer: 02/15/2026
• Initial Report FDA Received Date: 02/13/2026
• Supplement Report FDA Received Date: 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/04/2025
• 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