MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RX LOCKING DEVICE AND BIOPSY CAP; ENDOSCOPE CHANNEL ACCESSORY

Model Number	M00545260
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1: there were two physicians reported: dr.(b)(6).Block h6: imdrf device code a0501 captures the reportable event of the sponge detachment.
Event or Problem Description
It was reported to boston scientific corporation that rx locking / biopsy cap was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, the duodenoscope could no longer aspirate due to an obstruction in the channel.Multiple attempts were made in the operating room to unclog the endoscope; however, these efforts were unsuccessful.The procedure was unable to be completed as a result of this event.Reportedly, a water-soluble lubricant to the top of the biopsy cap, prior to use.The following day, a renewed attempt to clear the blockage was made.After several maneuvers, the obstruction was successfully removed.The obstruction was identified as a piece of foam from the biopsy cap.There were no patient complications reported as a result after this event.
Event or Problem Description
It was reported to boston scientific corporation that rx locking / biopsy cap was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, the duodenoscope could no longer aspirate due to an obstruction in the channel.Multiple attempts were made in the operating room to unclog the endoscope; however, these efforts were unsuccessful.The procedure was unable to be completed as a result of this event.Reportedly, a water-soluble lubricant to the top of the biopsy cap, prior to use.The following day, a renewed attempt to clear the blockage was made.After several maneuvers, the obstruction was successfully removed.The obstruction was identified as a piece of foam from the biopsy cap.There were no patient complications reported as a result after this event.
Additional Manufacturer Narrative
Block e1 (initial reporter first name and email address) has been updated based on the additional information received on october 20, 2025.Block e1: there were two physicians reported: dr.(b)(6) and dr.(b)(6).Block h6: imdrf device code a0501 captures the reportable event of the sponge detachment.

• Brand Name: RX LOCKING DEVICE AND BIOPSY CAP
• Common Device Name: ENDOSCOPE CHANNEL ACCESSORY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 22609568
• Report Number: 3005099803-2025-03605
• Device Sequence Number: 5384842
• Product Code: ODC
• UDI-Device Identifier: 08714729746676
• UDI-Public: (01)08714729746676(17)280406(10)36246878
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K010610
• 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): 10/21/2025

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: M00545260
• Device Catalogue Number: M00545260
• Device Lot Number: 0036246878
• 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: 07/07/2025
• Supplement Date Received by Manufacturer: 10/20/2025
• Initial Report FDA Received Date: 07/25/2025
• Supplement Report FDA Received Date: 10/21/2025
• Date Device Manufactured: 04/07/2025
• 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