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

Model Number	M00558920
Medical Device Problem Codes	Use of Device Problem (1670); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of rx tunnel detached.Imdrf impact code f2301 is being used to capture the reportable event of additional device required: extraction balloon and forceps.
Event or Problem Description
It was reported to boston scientific corporation that a cre rx biliary dilatation balloon was used in the pancreas during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat stenosis performed on (b)(6) 2025.During the procedure, after the dilation, the physician noticed that the black sheath present on a portion of the catheter remained inside the patient, specifically within the wirsung duct.It was reported that the detached piece inside the patient was retrieved using an extraction balloon and a grasping forceps.The procedure was completed with the original device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h2 (correction): block b5 and h6 has been updated based on information reviewed on december 17, 2025.Block h6: imdrf device code a0501 captures the reportable event of rx tunnel detached.Imdrf impact code f2301 is being used to capture the reportable event of additional device.Required: extraction balloon and forceps.
Event or Problem Description
It was reported to boston scientific corporation that a cre rx biliary dilatation balloon was used in the pancreas during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat stenosis performed on (b)(6) 2025.During the procedure, after the dilation, the physician noticed that the black sheath present on a portion of the catheter remained inside the patient, specifically within the wirsung duct.It was reported that the detached piece inside the patient was retrieved using an extraction balloon and a grasping forceps.The procedure was completed with the original device.There were no patient complications reported as a result of this event.*** correction*** note: it was reported that the device was used in the pancreas however, according to the ifu: the cre rx biliary balloon dilatation catheters are indicated for use in adults for endoscopic dilatation of the sphincter of oddi with or without prior sphincterotomy.The cre rx biliary balloon dilatation catheters may be used for injection of contrast medium for fluoroscopic visualization of the bile ducts.

• Brand Name: CRE RX
• 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: 23473152
• Report Number: 3005099803-2025-05830
• Device Sequence Number: 10237386
• Product Code: FGE
• UDI-Device Identifier: 08714729965473
• UDI-Public: (01)08714729965473(17)270815(10)34643309
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K172520
• 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
• Report Date (Section B): 01/13/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M00558920
• Device Catalogue Number: M00558920
• Device Lot Number: 0034643309
• 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: 10/16/2025
• Supplement Date Received by Manufacturer: 12/17/2025
• Initial Report FDA Received Date: 11/05/2025
• Supplement Report FDA Received Date: 01/13/2026
• Date Device Manufactured: 08/15/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown