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

Model Number	M00558360
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
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 a procedure on an unknown date.During the procedure, the device was inflated by the clinician and noticed that the contrast was leaking from the balloon.The procedure was completed with a second cre fixed wire dilatation balloon.No further information has been obtained despite good faith efforts.The anatomy location and procedure type are 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 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.
Event or Problem Description
It was reported to boston scientific corporation that a cre fixed wire dilatation balloon was attempted to be used in a procedure on an unknown date.During the procedure, the device was inflated by the clinician and noticed that the contrast was leaking from the balloon.The procedure was completed with a second cre fixed wire dilatation balloon.No further information has been obtained despite good faith efforts.The anatomy location and procedure type are 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 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.Block h11: (investigation result) the returned cre fixed wire dilatation balloon was analyzed, and a visual examination did not note any damages.Functional testing of the device found the balloon had a pinhole located approximately at 62 mm from the tip of the device, which was confirmed during microscopic inspection.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of balloon leak was confirmed.During the product analysis, it was found that the balloon had a pinhole located approximately at 62 mm from the tip of the device.The pinhole found is likely to have occurred due to procedural factors such as excess of pressure, interaction with other devices, or anatomical conditions.Also, it is possible that interaction with a sharp surface during or previous to the procedure, could have caused the physical damage found on the distal section of the balloon.Therefore, the most probable root cause is adverse event related to procedure.

• 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 21294734
• Report Number: 3005099803-2025-00206
• Device Sequence Number: 15752890
• Product Code: KNQ
• UDI-Device Identifier: 08714729195986
• UDI-Public: 08714729195986
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2025

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: 01/25/2026
• Device Model Number: M00558360
• Device Catalogue Number: M00558360
• Device Lot Number: 0033294136
• 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: 01/10/2025
• Supplement Date Received by Manufacturer: 03/03/2025
• Initial Report FDA Received Date: 02/03/2025
• Supplement Report FDA Received Date: 03/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/26/2024
• 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