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

Model Number	M00545101
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	01/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that autocap rx was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure for the treatment of stones on (b)(6) 2026.During the procedure, the foam piece from the autocap rx detached from the cap.The procedure was completed with a second autocap rx.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
Block e1: (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 autocap rx was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure for the treatment of stones on (b)(6) 2026.During the procedure, the foam piece from the autocap rx detached from the cap.The procedure was completed with a second autocap rx.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 february 3, 2026: it was reported that the anatomy location of the procedure is common bile duct.
Additional Manufacturer Narrative
Additional information: block b5 (describe event or problem).Block e1: (b)(6).Block h6: imdrf device code a0501 captures the reportable event of the sponge detachment.

• Brand Name: AUTOCAP RX
• Common Device Name: ENDOSCOPE CHANNEL ACCESSORY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): NOLATO CONTOUR INC; 660 vandeberg street; baldwin WI 54002
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 24240544
• Report Number: 3005099803-2026-00411
• Device Sequence Number: 8970811
• Product Code: ODC
• UDI-Device Identifier: 08714729994695
• UDI-Public: (01)08714729994695(17)280512(10)21306085
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K210353
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/27/2026

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: M00545101
• Device Catalogue Number: 4510
• Device Lot Number: 0021306085
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2026
• Supplement Date Received by Manufacturer: 02/03/2026; 04/30/2026
• Initial Report FDA Received Date: 02/02/2026
• Supplement Report FDA Received Date: 02/24/2026; 05/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2025
• 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