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

Model Number	M00545101
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block 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 a0413 captures the reportable event of the material separation.
Event or Problem Description
It was reported to boston scientific corporation that an autocap rx was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During the procedure, a bristle disc from the autocap rx was loosened and pushed through the scope into the patient.After stent placement, the bristle disc was retrieved from the patient.The procedure was completed with this device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Blocks d4 (lot number and expiration date), and h4 (manufacture date) have been updated.Block h6: imdrf device code a0413 captures the reportable event of the material separation.Block h11: the returned autocap rx was analyzed; the returned device indicated no problems.Visual inspection observed no damages or defects to the autocap assembly.The device was disassembled to inspect the biopsy cap.Upon inspecting the biopsy cap, it was noted that one of the bristle disks is missing.The reported complaint was confirmed.During product analysis, it was noted that one of the seven bristle disks located inside the biopsy cap is missing.A photo provided by the customer demonstrated the missing bristle disk.The bristle disks are located inside the biopsy cap and are stacked in place between the foam insert and the shutter helix.It is likely that during the procedure interactions with the scope and accessories passing through the device, the stacked bristle disks escaped the shutter helix and bottom plug.Therefore, based on all gathered information, the probable cause of the reported event was determined to be adverse event related to procedure, which indicates that factors of the procedure, including passage of accessories through the autocap device during normal use, caused or contributed to the reported event.
Event or Problem Description
It was reported to boston scientific corporation that an autocap rx was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During the procedure, a bristle disc from the autocap rx was loosened and pushed through the scope into the patient.After stent placement, the bristle disc was retrieved from the patient.The procedure was completed with this device.There were no patient complications reported as a result of 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 20440377
• Report Number: 3005099803-2024-04936
• Device Sequence Number: 15476584
• Product Code: ODC
• UDI-Device Identifier: 08714729994695
• UDI-Public: 08714729994695
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M00545101
• Device Catalogue Number: 4510
• Device Lot Number: 0019685724
• 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: 09/19/2024
• Supplement Date Received by Manufacturer: 11/27/2024
• Initial Report FDA Received Date: 10/14/2024
• Supplement Report FDA Received Date: 12/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown