MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CRE PRO; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M00558700
Medical Device Problem Codes	Burst Container or Vessel (1074); Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0402 captures the reportable event of a balloon burst.Imdrf device code a0501 captures the reportable event of balloon detachment.
Event or Problem Description
It was reported to boston scientific corporation that a cre pro wireguided dilatation balloon was attempted to be used in the esophagus during an esophageal dilation procedure to treat esophageal stenosis performed on (b)(6) 2026.During the procedure, the nurse reported performing sequential dilation from 15-18 mm up to 7 atm, per instruction for use (ifu).While maintaining inflation for 60 to 90 seconds, the balloon broke.It was reported that no piece of the balloon detached inside the patient.The procedure was completed with another cre pro wireguided dilatation balloon.There were no patient complications reported as a result of this event and the patient condition following procedure was reported to have fully recovered.
Event or Problem Description
It was reported to boston scientific corporation that a cre pro wireguided dilatation balloon was attempted to be used in the esophagus during an esophageal dilation procedure to treat esophageal stenosis performed on (b)(6) 2026.During the procedure, the nurse reported performing sequential dilation from 15-18 mm up to 7 atm, per instruction for use (ifu).While maintaining inflation for 60 to 90 seconds, the balloon broke.It was reported that no piece of the balloon detached inside the patient.The procedure was completed with another cre pro wireguided dilatation balloon.There were no patient complications reported as a result of this event and the patient condition following procedure was reported to have fully recovered.
Additional Manufacturer Narrative
Block h6: imdrf device code a0402 captures the reportable event of a balloon burst.Imdrf device code a0501 captures the reportable event of balloon detachment.Block h11: investigation results the cre pro wireguided 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 balloon burst.No other problems with the device were noted.According to the media analysis performed, boston scientific concludes the reported event of balloon burst and balloon detachment of device or device component were confirmed.However, based on the evidence provided, it was reported that the documentation attached includes pictures where it can be observed the balloon with evidence of burst.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 PRO
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• 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: 24758521
• Report Number: 3005099803-2026-01185
• Device Sequence Number: 8771933
• Product Code: FGE
• UDI-Device Identifier: 08714729797586
• UDI-Public: (01)08714729797586(17)280313(10)36073951
• Combination Product (Y/N): N
• Initial Reporter Country: CS
• PMA/510(K) Number: K112994
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/29/2026

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: M00558700
• Device Catalogue Number: M00558700
• Device Lot Number: 0036073951
• 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: 03/06/2026
• Supplement Date Received by Manufacturer: 04/09/2026; 06/05/2026
• Initial Report FDA Received Date: 04/01/2026
• Supplement Report FDA Received Date: 05/04/2026; 06/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2025
• 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