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

Model Number	M00515220
Medical Device Problem Codes	Break (1069); Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2025
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 corporation that a coredx? was used in the lung during a biopsy procedure performed on (b)(6) 2025.During the procedure, when the cup was opened at the target site and the handle was gripped, the jaws failed to close.The pull wire appears to have become separated.Another coredx? was used to complete the procedure.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a051104 captures the reportable event of jaws failure to close.Block h11: the returned coredx biopsy forceps was analyzed.Visual and microscope inspection observed the links were detached, and core wire attached was broke.Due to the device condition, functional test cannot be performed to determine if the device did not have smooth movement.With all the available information, boston scientific concludes the reported event was confirmed.Because the links were detached, the jaws cannot open and close.Additionally, the core wire attachment was broken, causing the links to not function correctly.This issue could have occurred due to excess manipulation against this unit.It is most likely that as part of the device manipulation during the procedure, an excess of force was applied to the device such as during insertion through another device, or by the interaction with the scope.Due to these conditions, the jaws were not able to close.Therefore, all compiled information on this investigation determines that the most probable cause is "adverse event related to procedure" since the evidence shows that the adverse event occurred during the procedure and the device had no influence on the event.
Event or Problem Description
It was reported to boston scientific corporation that a coredx? was used in the lung during a biopsy procedure performed on (b)(6) 2025.During the procedure, when the cup was opened at the target site and the handle was gripped, the jaws failed to close.The pull wire appears to have become separated.Another coredx? was used to complete the procedure.There were no patient complications as a result of this event.

• 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: 23293852
• Report Number: 3005099803-2025-05308
• Device Sequence Number: 4861993
• Product Code: EOQ
• UDI-Device Identifier: 08714729971054
• UDI-Public: (01)08714729971054(17)271126(10)35369298
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2025

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: 0035369298
• 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: 09/19/2025
• Supplement Date Received by Manufacturer: 11/11/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 12/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/26/2024
• 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