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

Model Number	M00558880
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of balloon rx tunnel detachment.
Event or Problem Description
It was reported to boston scientific corporation that a cre rx dilatation balloon was attempted to be used in the ampulla during an endoscopic retrograde cholangiopancreatography (ercp) procedure for stone treatment on (b)(6) 2026.During the procedure, resistance was felt by the physician when passing the balloon down the working channel.Upon exchange and retrieval, resistance was encountered again and the black catheter segment housing the guidewire (rapid exchange or rx tunnel) began to peel off.The rx tunnel dislodged into the working channel of the duodenal scope and forceps were used to remove it from the scope.It was reported that no portion of the detached piece fell into the patient.A photo of the complaint device showed the rx tunnel detached outside the patient.The procedure was completed with another cre rx dilatation balloon.There were no patient complications reported as a result of this event.The patient condition following procedure was reported to have fully recovered.
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of balloon rx tunnel detachment.Block h11: investigation results.The device was not returned for analysis; therefore, a technical analysis could not be performed.However, media analysis showing evidence that the rx tunnel was detached.No other problems with the device were noted.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of unable to exclude device problem.
Event or Problem Description
It was reported to boston scientific corporation that a cre rx dilatation balloon was attempted to be used in the ampulla during an endoscopic retrograde cholangiopancreatography (ercp) procedure for stone treatment on (b)(6) 2026.During the procedure, resistance was felt by the physician when passing the balloon down the working channel.Upon exchange and retrieval, resistance was encountered again and the black catheter segment housing the guidewire (rapid exchange or rx tunnel) began to peel off.The rx tunnel dislodged into the working channel of the duodenal scope and forceps were used to remove it from the scope.It was reported that no portion of the detached piece fell into the patient.A photo of the complaint device showed the rx tunnel detached outside the patient.The procedure was completed with another cre rx dilatation balloon.There were no patient complications reported as a result of this event.The patient condition following procedure was reported to have fully recovered.

• 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: 24366786
• Report Number: 3005099803-2026-00627
• Device Sequence Number: 12065846
• Product Code: FGE
• UDI-Device Identifier: 08714729965435
• UDI-Public: (01)08714729965435(17)271017(10)35085466
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2026

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: 0035085466
• 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: 01/20/2026
• Supplement Date Received by Manufacturer: 02/19/2026
• Initial Report FDA Received Date: 02/17/2026
• Supplement Report FDA Received Date: 03/16/2026
• Date Device Manufactured: 10/17/2024
• 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
• Patient Sex: Female