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

Model Number	M00545261
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	10/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of the sponge detached.
Event or Problem Description
It was reported to boston scientific corporation that an rx locking device and biopsy cap was used during a procedure performed on (b)(6) 2025.During the procedure, the biopsy cap sponge became dislodged and fell into the scope channel.The cap was manipulated using the distal tip wire holder, and lubricant was applied to the balloon catheter to assist in the process.There were no patient complications reported as a result after this event.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Additional information: block b5 (describe event or problem) and block h6 (imdrf impact codes) has been updated.Block h6: imdrf device code a0501 captures the reportable event of the sponge detached.Block bh11: correction to block e1 (initial reporter facility name, city and zip/post code).
Event or Problem Description
It was reported to boston scientific corporation that an rx locking device and biopsy cap was used during a procedure performed on (b)(6) 2025.During the procedure, the biopsy cap sponge became dislodged and fell into the scope channel.The cap was manipulated using the distal tip wire holder, and lubricant was applied to the balloon catheter to assist in the process.It is unknown if the sponge was successfully removed from the scope.There were no patient complications reported as a result after this event.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.Additional information was received on january 24, 2026: it was reported that during an endoscopic retrograde cholangiopancreatography (ercp) procedure in the common bile duct, a sponge fragment inadvertently fell into the patient.The physician was able to retrieve it without problem, and the procedure was completed using the seal biopsy cap.

• 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: 24193450
• Report Number: 3005099803-2026-00323
• Device Sequence Number: 9549973
• Product Code: ODC
• UDI-Device Identifier: 08714729296614
• UDI-Public: (01)08714729296614(17)280922(10)37521409
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2026

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: M00545261
• Device Catalogue Number: 4526
• Device Lot Number: 0037521409
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/31/2025
• Supplement Date Received by Manufacturer: 01/24/2026
• Initial Report FDA Received Date: 01/27/2026
• Supplement Report FDA Received Date: 02/18/2026
• Date Device Manufactured: 09/23/2025
• 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 Age: 79 YR
• Patient Sex: Female
• Patient Race: White