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

Model Number	M00558880
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During pt's ercp [(endoscopic retrograde cholangiopancreatography)], there was resistance felt by the md while passing the cre biliary balloon dilation catheter down the working channel but was unable to properly utilize equipment for its intended purpose.Upon exchanging, resistance was once again felt by the md and then a black straw like piece came out of the working channel of the duodenal scope.It should be noted that the foreign body never entered the patient.Upon further investigation after the case, it was determined that the guide wire sheath broke off the dilation balloon during insertion.

• Brand Name: CRE¿ RX
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 24229058
• Report Number: 24229058
• Device Sequence Number: 10229304
• Product Code: FGE
• UDI-Device Identifier: 08714729965435
• UDI-Public: (01)08714729965435
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 01/21/2026
• Report Date (Section F): 01/21/2026

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: M00558880
• Device Catalogue Number: M00558880
• Device Lot Number: 35085466
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 02/02/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/02/2026
• 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
• Patient Sex: Female
• Date Report Sent to FDA: 01/21/2026