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

Model Number	M00545260
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
It was reported to boston scientific corporation that rx locking / biopsy cap was used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.It was reported that during a procedure on (b)(6) 2025 the sponge of the biopsy cap became lodged in the duodenoscope.A water-soluble lubricant to the top of the biopsy cap, prior to use.The foam piece was retrieved during scope cleaning and sterilization.Reportedly, the scope had to be sent for repair.There were no patient complications reported as a result after this event.
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.Block h11: investigation results.The returned sponge from rx locking device and biopsy cap was visually inspected.Only the sponge was returned, and it was observed damaged.It is possible that the procedural factors, such as handling of the device, could have resulted in the damage encountered in the device.Based on the analysis of the returned device and all available information, the probable cause of the reported event is "adverse event related to procedure" because the adverse event occurred during the procedure and the device had no influence on event.Sponge detachment is likely to occur during preparation for procedures while devices are passing through the biopsy cap.However, the reported event of scope damaged/defective cannot be confirmed because the scope has not been returned for analysis.Therefore, the root cause of the reported damaged scope cannot be confirmed.For this reason, this event will be classified as "cause not established.".
Event or Problem Description
It was reported to boston scientific corporation that rx locking / biopsy cap was used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.It was reported that during a procedure on (b)(6) 2025 the sponge of the biopsy cap became lodged in the duodenoscope.A water-soluble lubricant to the top of the biopsy cap, prior to use.The foam piece was retrieved during scope cleaning and sterilization.Reportedly, the scope had to be sent for repair.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.Block h11: investigation results: the returned sponge from rx locking device and biopsy cap was visually inspected.Only the sponge was returned, and it was observed damaged.It is possible that the procedural factors, such as handling of the device, could have resulted in the damage encountered in the device.Based on the analysis of the returned device and all available information, the probable cause of the reported event is "adverse event related to procedure" because the adverse event occurred during the procedure and the device had no influence on event.Sponge detachment is likely to occur during preparation for procedures while devices are passing through the biopsy cap.However, the reported event of scope damaged/defective cannot be confirmed because the scope has not been returned for analysis.Therefore, the root cause of the reported damaged scope cannot be confirmed.For this reason, this event will be classified as "cause not established.".
Event or Problem Description
It was reported to boston scientific corporation that rx locking / biopsy cap was used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.It was reported that during a procedure on (b)(6) 2025 the sponge of the biopsy cap became lodged in the duodenoscope.A water-soluble lubricant to the top of the biopsy cap, prior to use.The foam piece was retrieved during scope cleaning and sterilization.Reportedly, the scope had to be sent for repair.There were no patient complications reported as a result after this event.

• 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: 22609633
• Report Number: 3005099803-2025-03606
• Device Sequence Number: 20179536
• 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,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?: Device Returned to Manufacturer
• 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: 09/16/2025; 10/20/2025
• Initial Report FDA Received Date: 07/25/2025
• Supplement Report FDA Received Date: 10/09/2025; 10/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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