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

Model Number	M00545470
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	02/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an rx locking device and biopsy cap was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2026, to treat cholangitis.During the procedure, a sphinctertome device was advanced through the working channel, at which point the sponge became dislodged and lodged within the channel.This obstruction prevented additional devices from being passed through the working channel.The sponge was subsequently retrieved using a brush.The procedure was then completed with a different scope and a new rx locking device.There were no patient complications reported as a result after this event.
Additional Manufacturer Narrative
Block d4 and h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block e1: (b)(6).Block h6: imdrf device code a0501 captures the reportable event of the sponge detached.Block h11: investigation results the product was not returned for evaluation to determine whether a device defect was present.Therefore, no analysis could be conducted, and the reported issue could not be confirmed.Based on the event description and the information provided by the customer, there is insufficient evidence to determine whether the sponge detachment from the device or device component resulted from physician technique during the procedure or from a device malfunction.Therefore, unable to exclude device problem has been selected as the most probable cause for this event.

• Brand Name: RX LOCKING DEVICE
• 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: 24544736
• Report Number: 3005099803-2026-00867
• Device Sequence Number: 12161853
• Product Code: ODC
• UDI-Device Identifier: 08714729746706
• UDI-Public: (01)08714729746706
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/09/2026

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: M00545470
• Device Catalogue Number: M00545470
• 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: 02/09/2026
• Initial Report FDA Received Date: 03/09/2026
• 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