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

Model Number	M00558350
Medical Device Problem Codes	Leak/Splash (1354); Use of Device Problem (1670); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2025
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 fixed wire dilatation balloon was used in the esophagus during a balloon dilatation procedure performed on (b)(6) 2025.During the procedure, it was reported that a balloon leakage was noticed.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.Note: the instructions for use (ifu) indicate that this balloon should not be pre-inflated prior to use in the procedure.However, the customer reported that balloon was pre-inflated prior to use in the patient.
Event or Problem Description
It was reported to boston scientific corporation that a cre fixed wire dilatation balloon was used in the esophagus during a balloon dilatation procedure performed on (b)(6) 2025.During the procedure, it was reported that a balloon leakage was noticed.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.Note: the instructions for use (ifu) indicate that this balloon should not be pre-inflated prior to use in the procedure.However, the customer reported that balloon was pre inflated prior to use in the patient.***additional information*** based on the gfe response on 04nov2025 that the catheter kinked, supplement report for correction was created.
Additional Manufacturer Narrative
Block h11 (correction): block b5, block h2, block h6 have been corrected.Block h6: imdrf device code a0504 captures the reportable event of balloon leak in the esophagus.
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 fixed wire dilatation balloon was analyzed, and a visual inspection found no physical damage with the device.Functional evaluation found that the balloon was inflated without problem and was able to hold pressure.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of balloon leak was not confirmed.The returned balloon has no physical damage.The balloon was able to be inflated and hold pressure.Based on all gathered information, the most probable root cause is device problem excluded.A labeling review was performed and, from the information available, this device was not used per the instructions for use (ifu) / product label.
Event or Problem Description
It was reported to boston scientific corporation that a cre fixed wire dilatation balloon was used in the esophagus during a balloon dilatation procedure performed on (b)(6) 2025.During the procedure, it was reported that a balloon leakage was noticed.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.Note: the instructions for use (ifu) indicate that this balloon should not be pre-inflated prior to use in the procedure.However, the customer reported that balloon was pre inflated prior to use in the patient.Additional information received november 4, 2025.It was reported that the catheter kinked.

• Brand Name: CRE FIXED WIRE
• 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: 23473067
• Report Number: 3005099803-2025-05824
• Device Sequence Number: 16091628
• Product Code: KNQ
• UDI-Device Identifier: 08714729202004
• UDI-Public: (01)08714729202004(17)260322(10)33691510
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: EXEMPT
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/27/2026

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 Expiration Date: 03/22/2026
• Device Model Number: M00558350
• Device Catalogue Number: M00558350
• Device Lot Number: 0033691510
• 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: 10/16/2025
• Supplement Date Received by Manufacturer: 10/16/2025; 02/04/2026
• Initial Report FDA Received Date: 11/05/2025
• Supplement Report FDA Received Date: 11/14/2025; 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/22/2024
• 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