MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION COREDX?; BRONCHOSCOPE (FLEXIBLE OR RIGID)

Model Number	M00515220
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a051104 captures the reportable event of jaws failure to close.
Event or Problem Description
It was reported to boston scientific that a coredx biopsy forceps was used in the common bile duct during a percutaneous cholangioscopy with biopsy procedure performed on (b)(6) 2025.During the procedure, it was noted that the jaws of the forceps would not close.The forceps were removed together with the spyglass discovery scope.There were no reported patient complications as a result of this event.No further information has been obtained despite good faith efforts.
Event or Problem Description
It was reported to boston scientific that a coredx biopsy forceps was used in the common bile duct during a percutaneous cholangioscopy with biopsy procedure performed on (b)(6) 2025.During the procedure, it was noted that the jaws of the forceps would not close.The forceps were removed together with the spyglass discovery scope.There were no reported patient complications as a result of this event.According to the information received on november 06, 2025; the procedure was completed with a different device.
Additional Manufacturer Narrative
Block h2: additional information: block b5 has been updated based on the additional information provided on november 06, 2025.Block h6: imdrf device code a051104 captures the reportable event of jaws failure to close.

• Brand Name: COREDX?
• Common Device Name: BRONCHOSCOPE (FLEXIBLE OR RIGID)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 22560770
• Report Number: 3005099803-2025-03416
• Device Sequence Number: 9528744
• Product Code: EOQ
• UDI-Device Identifier: 08714729971054
• UDI-Public: (01)08714729971054(17)270925(10)34927002
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K183085
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/28/2025

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: M00515220
• Device Catalogue Number: M00515220
• Device Lot Number: 0034927002
• 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: 06/27/2025
• Supplement Date Received by Manufacturer: 11/06/2025
• Initial Report FDA Received Date: 07/21/2025
• Supplement Report FDA Received Date: 11/28/2025
• Date Device Manufactured: 09/25/2024
• 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