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

Model Number	M00558350
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: imdrf device code a041001 captures the reportable event of a balloon pinhole in the esophagus.Block h11: investigation results.The returned cre fixed wire dilatation balloon was analyzed, and a visual evaluation noted no damages.Functional inspection was performed, the balloon was inflated without any problem; however, it was not able to hold the pressure due to pinhole found in the balloon, located approximately at 80 mm from the proximal end of the balloon.No other problems with the device were noted.With all the available information, boston scientific (bsc) concludes the reported event of balloon pinhole was confirmed.It is possible that the pinhole found in the balloon occurred due to procedural factors such as excess pressure, interaction with other devices, or anatomical conditions.Also, it is possible that interaction with a sharp surface during or after the procedure could have caused the pinhole on the distal section of the balloon.Therefore, the most probable root cause is an adverse event related to procedure.
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 a gastrointestinal dilation procedure to treat esophageal stenosis.The exact procedure date is unknown.During the procedure, dilation was unable to perform properly, and when it was checked outside the patient, a pinhole was found.The procedure was completed with another cre fixed wire dilatation balloon.There were no patient complications reported as a result of this 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 a gastrointestinal dilation procedure to treat esophageal stenosis.The exact procedure date is unknown.During the procedure, dilation was unable to perform properly, and when it was checked outside the patient, a pinhole was found.The procedure was completed with another cre fixed wire dilatation balloon.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 a041001 captures the reportable event of a balloon pinhole in the esophagus.

• 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: 22151151
• Report Number: 3005099803-2025-02496
• Device Sequence Number: 15362066
• Product Code: KNQ
• UDI-Device Identifier: 08714729202004
• UDI-Public: (01)08714729202004(17)261127(10)35375963
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 07/29/2025

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 Model Number: M00558350
• Device Catalogue Number: M00558350
• Device Lot Number: 0035375963
• 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: 05/13/2025
• Supplement Date Received by Manufacturer: 07/07/2025
• Initial Report FDA Received Date: 06/05/2025
• Supplement Report FDA Received Date: 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/27/2024
• 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