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

Model Number	M00558350
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a020504 captures the reportable event of a tear, rip, or hole in the device packaging.Block b3: approximated based on the date the manufacturer became aware of the event.
Event or Problem Description
It was reported to boston scientific corporation that a cre fixed wire dilatation balloon was received by the customer on an unknown date.Upon receipt of the shipment, it was reported that one device had a cut in the packaging.The device was not used in a procedure.A photo of the complaint device was provided and showed the packaging to be cut.No further information has been obtained despite good faith efforts the patient was not present at the time of the event and 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 received by the customer on an unknown date.Upon receipt of the shipment, it was reported that one device had a cut in the packaging.The device was not used in a procedure.A photo of the complaint device was provided and showed the packaging to be cut.No further information has been obtained despite good faith efforts.The patient was not present at the time of the event and there were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a020504 captures the reportable event of a tear, rip, or hole in the device packaging.Block b3: approximated based on the date the manufacturer became aware of the event.Block h11: investigation results the cre fixed wire dilatation balloon device was not returned for analysis.A technical analysis could not be performed.However, a media analysis was performed on the photos provided by the complainant where it can be observed that the pouch packaging exhibits evidence of a rip.No other problems with the device were noted.According to the media analysis performed, boston scientific concludes the reported event of packaging tear, rip or hole in device packaging was confirmed.Based on the evidence provided, it was reported that the documentation attached includes pictures where it can be observed the pouch packaging exhibits evidence of a rip.The conclusion is acceptable because of the analysis of the available information in the complaint did not determine a more specific complaint cause, in addition, without proper evaluation of the device, it remains unknown the most probable causes that contributed to the event.Therefore, the most probable root cause of the clinical observations is cause not established.A review of the device history record (dhr) was performed.The review of the dhr identified that there were no process related non-conformances, scrap, or rework performed during the production that could explain the event.The reviews ensure each device meets specification prior to release for use.There is no indication the device manufacturing process contributed to the reported complaint.

• 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: 24796392
• Report Number: 3005099803-2026-01242
• Device Sequence Number: 18818258
• Product Code: KNQ
• UDI-Device Identifier: 08714729202004
• UDI-Public: (01)08714729202004(17)271219(10)38228019
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2026

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: M00558350
• Device Catalogue Number: M00558350
• Device Lot Number: 0038228019
• 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: 03/11/2026
• Supplement Date Received by Manufacturer: 04/10/2026
• Initial Report FDA Received Date: 04/07/2026
• Supplement Report FDA Received Date: 05/07/2026
• Date Device Manufactured: 12/19/2025
• 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