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

Model Number	M00545471
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	03/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an rx locking device and biopsy cap was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2026, for the treatment of stones in the common bile duct.During the procedure, the sponge from the clear biopsy cap was pushed through the cap and into the endoscope.The physician attempted to retrieve the sponge using biopsy forceps; however, the sponge began to fragment during removal.The endoscope was then taken to the reprocessing room, where they attempted to use forceps to push the remaining sponge material through the working channel for removal.They successfully flushed out the remaining fragments using irrigation.The procedure was completed using a second rx locking/biopsy cap of the same device type.No patient complications were reported as a result of this event.
Additional Manufacturer Narrative
Block d4 and h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: imdrf device code a0501 captures the reportable event of the sponge detached.Block h11: investigation result: based on the available information, boston scientific concludes that, without a proper evaluation of the device, the most probable cause of the reported event cannot be determined.Although the customer provided a photo and media review confirmed that the sponge was detached from the biopsy cap, the device was not returned; therefore, a technical analysis could not be performed.Due to the absence of the device and the limited evidence available, the most probable cause remains unknown.Media review: media inspection was performed, and it was observed that the sponge was detached from the biopsy cap.Device history record (dhr) review: a review of the manufacturing documentation for this device was unable to be performed as the lot number is unknown.Risk review: a review of the rx locking device and biopsy cap dfmea was completed and confirmed that the event of sponge detachment of device or device component 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.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause not established.

• Brand Name: RX LOCKING DEVICE
• 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: 24837704
• Report Number: 3005099803-2026-01310
• Device Sequence Number: 18697019
• Product Code: ODC
• UDI-Device Identifier: 08714729337768
• UDI-Public: (01)08714729337768
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/09/2026

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: M00545471
• Device Catalogue Number: M00545471
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2026
• Initial Report FDA Received Date: 04/09/2026
• 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