MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AutoCap RX; Endoscope Channel Accessory

Model Number	M00545101
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2026
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 performed on (b)(6) 2026.The procedure was completed with this device.There were no patient complications reported.During the scope cleaning, a small rubber filter of the autocap rx was found inside the scope.
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to provide a lot number.Therefore, the manufacture and expiration dates are unknown.Block h6: imdrf device code a0413 captures the reportable event of material separation.
Event or Problem Description
It was reported to boston scientific corporation that autocap rx was used during an endoscopic retrograde cholangeopancreatography (ercp) procedure on (b)(6) 2026.During scope reprocessing, a small rubber filter of the autocap rx was found inside the scope.The procedure was completed was completed.There were no patient complications reported as a result after this event.
Additional Manufacturer Narrative
Block h11: investigation summary: based on the available information, the root cause of the material separation cannot be established, as the product has not been returned for analysis.Device technical analysis: the device has not been returned for analysis.Therefore, the root cause of the reported material separation cannot be confirmed.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A similar complaint review was completed.There were no emerging trends identified that warrant further action.Investigation conclusion: based on the available information and in the absence of device return, the root cause of the reported clinical observations cannot be established.

• 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 ; +1(914)571-6918
• MDR Report Key: 25162770
• Report Number: 3005099803-2026-01873
• Device Sequence Number: 8660591
• Product Code: ODC
• UDI-Device Identifier: 08714729994695
• UDI-Public: (01)08714729994695
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K210353
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/17/2026

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: M00545101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2026
• Supplement Date Received by Manufacturer: 07/13/2026; 08/25/2026
• Initial Report FDA Received Date: 05/13/2026
• Supplement Report FDA Received Date: 08/11/2026; 09/17/2026
• 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