MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CRE RX; Catheter, Biliary, Diagnostic

Model Number	M00558890
Medical Device Problem Codes	Entrapment of Device (1212); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a cre rx dilatation balloon was used during a procedure performed on an unknown date.During the procedure, when a cre rx dilatation balloon was inserted into the working channel of the scope, the balloon got stuck halfway.The balloon was removed.It was reported that rx tunnel became loose from the purple shaft and was detached and left inside the scope unnoticed.During a separate procedure on march 27, 2026, the biopsy forceps pushed out a foreign material from the working channel of the scope and into the patient.Upon checking, it was positively identified to have come from the cre rx balloon from the previous procedure.The detached part was successfully retrieved with a grasper.There were no patient complications reported as a result of this event and the patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: imdrf device code a0501 captures the reportable event of rx tunnel detached.Block h11: investigation results the device was not returned for analysis and was reported to be disposed; therefore, a technical analysis could not be performed.With all the available information, boston scientific concludes that the reported event of rx tunnel detached could not be confirmed.The device was not returned because it was disposed.Without analysis of the actual device, there is a lack of objective evidence, or descriptive conditions of the event required to determine a probable root cause of the event.A review of the device history record (dhr) was performed.The review of the dhr identified that there were no process related non-conformances, scrap, or rework performed during the production that could explain the event.The reviews ensure each device meets specification prior to release for use.There is no indication the device manufacturing process contributed to the reported complaint.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause not established.

• 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 ; +1(914)571-6918
• MDR Report Key: 25023038
• Report Number: 3005099803-2026-01556
• Device Sequence Number: 8919753
• Product Code: FGE
• UDI-Device Identifier: 08714729965442
• UDI-Public: (01)08714729965442(17)280514(10)36525175
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K172520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2026

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: M00558890
• Device Catalogue Number: M00558890
• Device Lot Number: 0036525175
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2026
• Supplement Date Received by Manufacturer: 07/17/2026
• Initial Report FDA Received Date: 04/28/2026
• Supplement Report FDA Received Date: 07/31/2026
• Date Device Manufactured: 05/15/2025
• 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: Unknown