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

Model Number	M00545101
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure for the stone removal on (b)(6) 2025.During the procedure, the cap appeared damaged, and the sponge dislodged.Due to the addition of materials, the cap could not be replaced.The procedure was completed with the same device.There were no patient complications reported as a result after this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of the sponge detachment.Block h11: an autocap device was received for analysis.A visual inspection revealed no damage to the autocap housing.However, the sponge insert was noted to be protruding from the biopsy seal, and a cut was observed near the top cap insert.The insert was discolored, which is a sign of usage.No other damages were identified.The autocap was able to attach to and detach from the scope port without any issues.The reported complaint was confirmed.During product analysis, the failure observed is consistent with heavy usage as it is likely that damage to the cap in the form of a cut occurred when accessories were being fed down the cap allowing for the sponge to be displaced.Therefore, a review and analysis of the all the available information indicated that the most probable cause is adverse event related to procedure.A labeling review was performed, and the instructions for use (ifu) confirmed that the reported event is addressed through existing warnings and guidance.The ifu advises proper alignment of the device with the scope inlet and slow, straight insertion to prevent friction-related damage.It also recommends applying a water-soluble lubricant if resistance is encountered and instructs users not to use damaged devices, but to return them immediately to boston scientific.
Event or Problem Description
It was reported to boston scientific corporation that autocap was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure for the stone removal on (b)(6) 2025.During the procedure, the cap appeared damaged, and the sponge dislodged.Due to the addition of materials, the cap could not be replaced.The procedure was completed with the same device.There were no patient complications reported as a result after this event.

• 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: 22650291
• Report Number: 3005099803-2025-03663
• Device Sequence Number: 8762568
• Product Code: ODC
• UDI-Device Identifier: 08714729994695
• UDI-Public: (01)08714729994695(17)271127(10)20153911
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2025

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: 0020153911
• 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: 07/08/2025
• Supplement Date Received by Manufacturer: 10/14/2025
• Initial Report FDA Received Date: 07/29/2025
• Supplement Report FDA Received Date: 11/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/27/2024
• 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