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

Model Number	M00558930
Medical Device Problem Codes	Entrapment of Device (1212); Problem with Sterilization (1596)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a180305 captures the reportable event of a device being stuck in scope, reprocessed, and used in another procedure.
Event or Problem Description
Note: this report pertains to one of four procedures involving one cre rx biliary dilatation balloon.It was reported to boston scientific corporation that a cre rx biliary dilatation balloon was used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure performed on (b)(6) 2025, the cre rx tunnel (black sheath) was detached and stuck in the endoscope.Scope was put through cleaning process, and included manual clean, and auto washing procedure.Without the team being aware, the scope was used on another procedure on (b)(6) 2025, still no realization of sheath inside the working channel.Then the scope was used in another two separate procedures on (b)(6) 2025, in the second cased performed on (b)(6) 2025, it was observed that the black sheath come out of the biopsy port on the scope when they withdrew the forceps back into the endoscope.It was reported that the rx tunnel did not detach inside the patient.They have to test the first patient (source) to see if there is any for blood-borne pathology (bbp) which could have been passed on to other patients at later procedures.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block h2 (additional information): block b5 (describe event or problem) has been updated.Block h6: imdrf device code a180305 captures the reportable event of a device being stuck in scope, reprocessed, and used in another procedure.
Event or Problem Description
Note: this report pertains to one of four procedures involving one cre rx biliary dilatation balloon.It was reported to boston scientific corporation that a cre rx biliary dilatation balloon was used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure performed on (b)(6) 2025, the cre rx tunnel (black sheath) was detached and stuck in the endoscope.Scope was put through cleaning process, and included manual clean, and auto washing procedure.Without the team being aware, the scope was used on another procedure on (b)(6) 2025, still no realization of sheath inside the working channel.Then the scope was used in another two separate procedures on (b)(6) 2025, in the second cased performed on (b)(6) 2025, it was observed that the black sheath come out of the biopsy port on the scope when they withdrew the forceps back into the endoscope.It was reported that the rx tunnel did not detach inside the patient.They have to test the first patient (source) to see if there is any for blood-borne pathology (bbp) which could have been passed on to other patients at later procedures.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.Additional information received on june 22, 2025: it was reported that the type of procedure performed on (b)(6) 2025, was upper gastrointestinal (gi), and the blood-borne pathology (bbp) test result performed on the first patient was clear.There were no patient complications reported related to the procedure performed on (b)(6) 2025, and the patient's condition at the conclusion of the procedure was reported to be stable.It was reported that the type of procedure performed on (b)(6) 2025, was upper gastrointestinal (gi) gastroscopy, and the procedure was able to be completed with normal gastroscopy.There were no patient complications reported related to the procedure performed on (b)(6) 2025, and the patient's condition at the conclusion of the procedure was reported to be stable.It was reported that the type of procedure performed on (b)(6) 2025 (1st case), was biopsy of stomach, and the anatomy location was at the stomach.The procedure was able to be completed with standard gastroscopy.There were no patient complications reported related to the procedure performed on (b)(6) 2025, and the patient's condition at the conclusion of the procedure was reported to be stable.

• 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 22311489
• Report Number: 3005099803-2025-02806
• Device Sequence Number: 8818762
• Product Code: FGE
• UDI-Device Identifier: 08714729965480
• UDI-Public: (01)08714729965480(17)270819(10)34665074
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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): 07/10/2025

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: M00558930
• Device Catalogue Number: M00558930
• Device Lot Number: 0034665074
• 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: 05/30/2025
• Supplement Date Received by Manufacturer: 06/22/2025
• Initial Report FDA Received Date: 06/23/2025
• Supplement Report FDA Received Date: 07/10/2025
• Date Device Manufactured: 08/19/2024
• 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: Unknown