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

Model Number	M00558710
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
"balloon would not hold pressure at 6 atm during dilation to 20mm diameter.Therefore, not being able to dilate at 20mm.Balloon removed and new one used without incidence.Balloon sequestered and given to [redacted] for follow up.".

• Brand Name: CRE¿ PRO
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 100 boston scientific way; marlborough MA 01752
• MDR Report Key: 25689826
• Report Number: 25689826
• Device Sequence Number: 9688148
• Product Code: FGE
• UDI-Device Identifier: 08714729797593
• UDI-Public: (01)08714729797593
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 05/26/2026
• Report Date (Section F): 05/27/2026

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: Other
• Device Model Number: M00558710
• Device Catalogue Number: M00558710
• Device Lot Number: 36176376
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 07/02/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/02/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 47 YR
• Patient Sex: Female
• Date Report Sent to FDA: 05/27/2026