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

Model Number	M00545260
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	04/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to report the lot number; therefore, the manufacture date and expiration date are unknown.Block h6: imdrf device code a0501 captures the reportable event of the sponge detached.
Event or Problem Description
It was reported to boston scientific corporation that rx locking / biopsy cap was used during an endoscopic retrograde cholangiopancreatography (ercp) with stent removal procedure performed on (b)(6) 2025.During the procedure, the physician was unable to pass instruments through the working channel of the scope.They were able to pull the stent using a biopsy forceps; however, it was very difficult to pass the forceps through the channel.The physician then attempted to pass a snare through the working channel.They were unable to pass the snare and switched to a new scope.During the scope cleaning they could not get the cleaning solution or water to suction through the working channel.The sponge from biopsy cap was discovered to be obstructing working channel.Reportedly, a water-soluble lubricant was applied on top of the biopsy cap prior to use.There were no patient complications reported as a result after this event.
Event or Problem Description
It was reported to boston scientific corporation that rx locking / biopsy cap was used during an endoscopic retrograde cholangiopancreatography (ercp) with stent removal procedure performed on (b)(6) 2025.During the procedure, the physician was unable to pass instruments through the working channel of the scope.They were able to pull the stent using a biopsy forceps, however, it was very difficult to pass the forceps through the channel.The physician then attempted to pass a snare through the working channel.They were unable to pass the snare and switched to a new scope.During the scope cleaning they could not get the cleaning solution or water to suction through the working channel.The sponge from biopsy cap was discovered to be obstructing working channel.Reportedly, a water-soluble lubricant was applied on top of the biopsy cap prior to use.There were no patient complications reported as a result after this event.Additional information was received on may 28, 2025: it was confirmed that the sponge detached into the scope working channel.
Additional Manufacturer Narrative
Additional information: b5.Block d4, h4: the complainant was unable to report the lot number; therefore, the manufacture date and expiration date are unknown.Block h6: imdrf device code a0501 captures the reportable event of the sponge detached.

• 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
• Manufacturer Contact: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 22087786
• Report Number: 3005099803-2025-02387
• Device Sequence Number: 6947547
• Product Code: ODC
• UDI-Device Identifier: 08714729746676
• UDI-Public: (01)08714729746676
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 06/16/2025

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: M00545260
• Device Catalogue Number: M00545260
• 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: 05/05/2025
• Supplement Date Received by Manufacturer: 05/28/2025
• Initial Report FDA Received Date: 05/27/2025
• Supplement Report FDA Received Date: 06/16/2025
• 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