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

Model Number	4510
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
: the complainant could not provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Mdrf device code a0413 captures the reportable event of a bristle disc found inside the ampulla.
Event or Problem Description
It was reported to boston scientific corporation that an autocap rx was used in the ampulla during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024 for the treatment of common bile duct stones.At the end of the procedure, during a plastic stent insertion, a bristle disc from the autocap rx was found in the ampulla.The physician reported the disc will be removed upon removal of the plastic stent.The procedure was completed using the original autocap.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): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; MA 01752
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 19825760
• Report Number: 3005099803-2024-03475
• Device Sequence Number: 18320189
• Product Code: ODC
• UDI-Device Identifier: 08714729994695
• UDI-Public: 08714729994695
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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
• Report Date (Section B): 07/25/2024

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 Model Number: 4510
• Device Catalogue Number: 4510
• 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: 06/26/2024
• Initial Report FDA Received Date: 07/25/2024
• 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
• Patient Sex: Unknown