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

Model Number	M00545261
Medical Device Problem Codes	Use of Device Problem (1670); Detachment of Device or Device Component (2907); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a rx locking / biopsy cap was used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure on (b)(6) 2025, for the treatment of bile duct stones.During the procedure, an attempt was made to pass a stone-removing balloon catheter through the endoscope's working channel.Resistance was encountered, and an obstruction was noted within the channel.As a result, the endoscope was removed from the patient, and the procedure could not be completed.Reportedly, it was discovered that a sponge was lodged in the working channel and could not be removed.It was also noted that water-soluble lubricant had not been applied to the top of the biopsy cap prior to its use.The endoscope was subsequently sent for repair.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.
Event or Problem Description
It was reported to boston scientific corporation that a rx locking / biopsy cap was used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure on (b)(6) 2025, for the treatment of bile duct stones.During the procedure, an attempt was made to pass a stone-removing balloon catheter through the endoscope's working channel.Resistance was encountered, and an obstruction was noted within the channel.As a result, the endoscope was removed from the patient, and the procedure could not be completed.Reportedly, it was discovered that a sponge was lodged in the working channel and could not be removed.It was also noted that water-soluble lubricant had not been applied to the top of the biopsy cap prior to its use.The endoscope was subsequently sent for repair.There were no patient complications reported as a result after this event.Additional information received on 24jun2025: it was reported that the procedure was completed with alternative device using duodenoscope.
Additional Manufacturer Narrative
Additional information: h6 (impact code).Block h6: imdrf device code a0501 captures the reportable event of the sponge detachment.

• 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 22341508
• Report Number: 3005099803-2025-02981
• Device Sequence Number: 9017350
• Product Code: ODC
• UDI-Device Identifier: 08714729296614
• UDI-Public: (01)08714729296614(17)280124(10)35705580
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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,Followup
• Report Date (Section B): 07/14/2025

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: 0035705580
• 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: 06/03/2025
• Supplement Date Received by Manufacturer: 06/24/2025
• Initial Report FDA Received Date: 06/26/2025
• Supplement Report FDA Received Date: 07/14/2025
• Date Device Manufactured: 01/24/2025
• 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