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	11/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 an autocap rx was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, a layer of silicone fragment of the autocap rx locking device broke off and fell into the scope.The procedure was completed with another of the same device.There were no patient complications reported as a result of 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.
Event or Problem Description
It was reported to boston scientific corporation that an autocap rx was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, a layer of silicone fragment of the autocap rx locking device broke off and fell into the scope.The procedure was completed with another of the same device.There were no patient complications reported as a result of 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 december 15, 2025: it was reported that the anatomy location of the procedure is bile duct.
Additional Manufacturer Narrative
Additional information: block b5 (describe event or problem).Block h6: imdrf device code a0413 captures the reportable event of material separation.
Additional Manufacturer Narrative
Additional information: block b5 (describe event or problem).Block h6: imdrf device code a0413 captures the reportable event of material separation.Block h11: one autocap device was received for analysis.Visual inspection observed no damages to the housing or the insert.Discoloration was observed on the sponge indicating it was used.The autocap was attached and detached from a scope port.No problems were identified.The device did not detach without pinching and pulling the top part of the house.The biopsy cap was disassembled.It was noted that only six bristle disks were found.Indicating one was detached.Detached bristle disc was returned with the complaint device in a separate bag.A review of the device history record (dhr) was performed.The review of the dhr identified that there were no process related non-conformances, scrap, or rework performed during the production that could explain the event.The reviews ensure each device meets specification prior to release for use.There is no indication the device manufacturing process contributed to the reported complaint.A risk review was completed and confirmed that the event of material separation was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.The reported complaint was confirmed.During product analysis, the bristle disks are located inside the biopsy cap and are stacked in place between the foam insert and the shutter helix and serve the purpose of guiding accessories all the way through to the bottom plug of the biopsy cap.It is likely that during the procedure interactions with the scope and potential accessories getting caught on the bristle disc led to one of the stacked bristle disks escaping the shutter helix and bottom plug.Therefore, based on all gathered information, the probable cause of the reported event was determined to be cause traced to component failure, which indicates an expected or random component failure without any design or manufacturing problem.
Event or Problem Description
It was reported to boston scientific corporation that an autocap rx was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, a layer of silicone fragment of the autocap rx locking device broke off and fell into the scope.The procedure was completed with another of the same device.There were no patient complications reported as a result of 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 december 15, 2025: it was reported that the anatomy location of the procedure is bile duct.

• 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: 23803075
• Report Number: 3005099803-2025-06711
• Device Sequence Number: 7622247
• Product Code: ODC
• UDI-Device Identifier: 08714729994695
• UDI-Public: (01)08714729994695(17)280424(10)21114609
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• 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: 0021114609
• 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: 11/24/2025
• Supplement Date Received by Manufacturer: 12/15/2025; 04/30/2026
• Initial Report FDA Received Date: 12/15/2025
• Supplement Report FDA Received Date: 01/09/2026; 05/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2025
• 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