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

Model Number	M00545101
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	06/14/2024
Type of Reportable Event	Malfunction
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 an autocap rx was used in pancreas during an endoscopic retrograde cholangiopancreatography (ercp) on (b)(6) 2024, for the treatment of pancreatic duct stones.During the procedure, a jagtome revolution was first advanced through the autocap into the pancreatic duct through a plastic stent.The wire was left behind and jagtome was removed out of the scope.A captivator ll round snare was advanced over the wire and passed through the autocap, down the working channel and out into the duodenum.When opening the snare to remove the plastic stent from the pancreatic duct, the sponge was noted around the wire of the snare.Reportedly, it was identified that the sponge attached to the snare wire came from the autocap upon disassembling.The procedure was completed using another of the same device and another scope.There was no patient complication 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: 19669414
• Report Number: 3005099803-2024-03200
• Device Sequence Number: 12471543
• Product Code: ODC
• UDI-Device Identifier: 08714729994695
• UDI-Public: 08714729994695
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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
• Report Date (Section B): 07/03/2024

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 Expiration Date: 09/27/2026
• Device Model Number: M00545101
• Device Catalogue Number: 4510
• Device Lot Number: 0018894017
• 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: 06/14/2024
• Initial Report FDA Received Date: 07/03/2024
• Date Device Manufactured: 09/28/2023
• 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