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

Model Number	M00545261
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	09/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that rx locking / biopsy cap was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on an unknown date.During the procedure, when the physician used rat tooth forceps to retrieve a stent, but the forceps became stuck.Upon investigation, it was found that the foam insert from the biopsy cap had dislodged and was lodged inside the scope.The procedure was completed using the same device.There were no patient complications reported as a result after this event.
Additional Manufacturer Narrative
Block b3: the exact date of the event is unknown.The provided event date was chosen as a best estimate based on the date that the manufacturer became aware of the event.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 rx locking / biopsy cap was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on an unknown date.During the procedure, when the physician used rat tooth forceps to retrieve a stent, but the forceps became stuck.Upon investigation, it was found that the foam insert from the biopsy cap had dislodged and was lodged inside the scope.The procedure was completed using the same device.There were no patient complications reported as a result after this event.
Additional Manufacturer Narrative
Block b3: the exact date of the event is unknown.The provided event date was chosen as a best estimate based on the date that the manufacturer became aware of the event.Block h6: imdrf device code a0501 captures the reportable event of the sponge detachment.Block h11: investigation results: the rx locking and biopsy cap device was not returned, but a media analysis was conducted based on the photo provided by the complainant.The image shows that sponge was outside the biopsy cap and shows the device label information.No additional issues with the device were identified.Based on the available information, boston scientific confirms the reported event of sponge detachment.The media analysis supports the observation of the sponge was outside the biopsy cap and shows the device label.However, since the device was not properly evaluated, the exact cause of the event remains unknown.As a result, the investigation findings and all information available concludes the most probable root cause is a cause not established.

• Brand Name: RX LOCKING DEVICE AND BIOPSY CAP
• 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: 23222449
• Report Number: 3005099803-2025-05157
• Device Sequence Number: 9648137
• Product Code: ODC
• UDI-Device Identifier: 08714729296614
• UDI-Public: (01)08714729296614(17)280521(10)36586127
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2025

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: M00545261
• Device Catalogue Number: 4526
• Device Lot Number: 0036586127
• 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: 09/16/2025
• Supplement Date Received by Manufacturer: 10/10/2025
• Initial Report FDA Received Date: 10/06/2025
• Supplement Report FDA Received Date: 10/30/2025
• Date Device Manufactured: 05/22/2025
• 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