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

Model Number	M00558500
Medical Device Problem Codes	Connection Problem (2900); Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a140101 captures the reportable event of balloon failure to deflate.
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 an esophagogastroduodenoscopy (egd) procedure to treat stricture performed on (b)(6) 2026.During the procedure, the nurse reported that the connection was not properly secured, and as a result, the balloon would not deflate enough to exit the scope.A photo of the complaint device was provided shows the device hub/luer type connector and the inflation port, however, no visible damage can be observed related to the reported event.The procedure was completed with another cre wireguided dilatation balloon device.No further information has been obtained despite good faith efforts.There were no patient complications have been reported as a result of this event.The patient condition at the conclusion of the procedure was reported to have full recovered.
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 an esophagogastroduodenoscopy (egd) procedure to treat stricture performed on (b)(6) 2026.During the procedure, the nurse reported that the connection was not properly secured, and as a result, the balloon would not deflate enough to exit the scope.A photo of the complaint device was provided shows the device hub/luer type connector and the inflation port, however, no visible damage can be observed related to the reported event.The procedure was completed with another cre wireguided dilatation balloon device.No further information has been obtained despite good faith efforts.There were no patient complications have been reported as a result of this event.The patient condition at the conclusion of the procedure was reported to have full recovered.
Additional Manufacturer Narrative
Block h6: imdrf device code a140101 captures the reportable event of balloon failure to deflate.Block h11: investigation results: investigation results: the device was not returned for analysis and was reported to be disposed; therefore, a technical analysis could not be performed.However, a media analysis was performed based on the pictures provided by the complainant where it can be observed the device and its ports, but no faults are determined.No other problems with the device were noted.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.Risk review: a risk review was completed and confirmed that the event of balloon failure to deflate was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of unable to exclude device problem.

• 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: 24278334
• Report Number: 3005099803-2026-00494
• Device Sequence Number: 13243473
• Product Code: KNQ
• UDI-Device Identifier: 08714729339434
• UDI-Public: (01)08714729339434(17)281027(10)38063252
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 03/06/2026

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: 0038063252
• 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: 01/13/2026
• Supplement Date Received by Manufacturer: 02/13/2026
• Initial Report FDA Received Date: 02/06/2026
• Supplement Report FDA Received Date: 03/06/2026
• 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