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

Model Number	M00558940
Medical Device Problem Codes	Entrapment of Device (1212); Use of Device Problem (1670); 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	11/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block b3: approximated based on the event date provided in the medwatch form ((b)(6) 2025).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 stomach and esophagus during an esophagogastroduodenoscopy (egd) procedure performed in (b)(6) 2025.The specific date is unknown.During the procedure, a biliary balloon dilatation catheter was inserted into an endoscope with a 2.8 mm working channel, which was too small for the device.The catheter met significant resistance during insertion and did not exit the distal tip of the scope.When the team pulled the device back out, the black rx sheath, which is not designed to detach, was torn off and remained in the biopsy channel.It was reported that no part of the detached piece fell into the patient.The procedure was completed with another cre rx dilatation balloon device.There were no patient complications reported as a result of this event.Note: the instruction for use (ifu) states that the cre rx biliary balloon dilatation catheter is designed to pass through an endoscope with a minimum 3.7mm working channel.However, the complainant reported that they used the device in a scope with too small of a working channel 2.8mm.
Additional Manufacturer Narrative
Block b3: approximated based on the event date provided in the medwatch form (november 2025).Block h6: imdrf device code a0501 captures the reportable event of balloon rx tunnel detachment.Block h11: investigation results investigation results: the device was not returned for analysis and was reported to be disposed; therefore, a technical analysis could not be performed.Device history records review: it was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Labeling review: the labeling review found evidence to suggest that the device was used in a manner inconsistent with the labelled indications."the cre rx biliary balloon dilatation catheter is designed to pass through an endoscope with a minimum 3.7mm working channel." however, it was reported that they used the device in a scope with too small of a working channel 2.8mm.The ifu contains detailed device information and instructions for the device use and there is no evidence that there is any issue with translation, wording, or graphics of the ifu/labeling information.Risk review: a risk review was completed and confirmed that the event of rx tunnel detachment of device or device component, device entrapment of device or device component, device difficult to advance and device use of device issue - user error were defined in the risk documentation.These event types have been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: based on all gathered information, the most probable root cause of this complaint is failure to follow instructions.
Event or Problem Description
It was reported to boston scientific corporation that a cre rx dilatation balloon was attempted to be used in the stomach and esophagus during an esophagogastroduodenoscopy (egd) procedure performed in (b)(6) 2025.The specific date is unknown.During the procedure, a biliary balloon dilatation catheter was inserted into an endoscope with a 2.8 mm working channel, which was too small for the device.The catheter met significant resistance during insertion and did not exit the distal tip of the scope.When the team pulled the device back out, the black rx sheath, which is not designed to detach, was torn off and remained in the biopsy channel.It was reported that no part of the detached piece fell into the patient.The procedure was completed with another cre rx dilatation balloon device.There were no patient complications reported as a result of this event.Note: the instruction for use (ifu) states that the cre rx biliary balloon dilatation catheter is designed to pass through an endoscope with a minimum 3.7mm working channel.However, the complainant reported that they used the device in a scope with too small of a working channel 2.8mm.

• 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: 24279791
• Report Number: 3005099803-2026-00498
• Device Sequence Number: 9927262
• Product Code: FGE
• UDI-Device Identifier: 08714729965497
• UDI-Public: (01)08714729965497(17)260426(10)31505643
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2026

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 Expiration Date: 04/26/2026
• Device Model Number: M00558940
• Device Catalogue Number: M00558940
• Device Lot Number: 0031505643
• 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: 01/12/2026
• Supplement Date Received by Manufacturer: 02/11/2026
• Initial Report FDA Received Date: 02/06/2026
• Supplement Report FDA Received Date: 03/06/2026
• Date Device Manufactured: 04/27/2023
• 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 Age: 41 YR
• Patient Sex: Male
• Patient Weight: 64 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White