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

Model Number	M00515220
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of pull wire break.
Event or Problem Description
It was reported to boston scientific corporation that a coredx pulmonary forceps was used in the lungs during a endoscopic ultrasonography-guided fine needle aspiration procedure on (b)(6) 2025.During the procedure, when the forceps were opened, the wire protrudes from the inside and the biopsy was unable to perform.The procedure was completed using another coredx pulmonary forceps.There were no reported patient complications as a result of this event.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of pull wire break.Block h11: investigation results.A coredx forceps was received for analysis.Visual examination of the returned device revealed that the links were detached, and the core wire attachment was dislocated.Based on the available information, the investigation indicates that the reported device issue was most likely related to procedural factors, including lesion characteristics, device handling, and the technique used during the procedure.These factors may have contributed to damage to the device components.Once the links detached, the jaws were unable to close as intended.It is also likely that, because the jaws could not close, the physician cut the device's outer jacket to facilitate removal from the scope and prevent further damage.A review of all available information supports that the most probable cause of the event is adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that a coredx pulmonary forceps was used in the lungs during a endoscopic ultrasonography-guided fine needle aspiration procedure on (b)(6) 2025.During the procedure, when the forceps were opened, the wire protrudes from the inside and the biopsy was unable to perform.The procedure was completed using another coredx pulmonary forceps.There were no reported 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: 23076005
• Report Number: 3005099803-2025-04740
• Device Sequence Number: 20030029
• Product Code: EOQ
• UDI-Device Identifier: 08714729971054
• UDI-Public: (01)08714729971054(17)280318(10)36102853
• 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): 11/19/2025

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: 0036102853
• 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: 08/26/2025
• Supplement Date Received by Manufacturer: 10/21/2025
• Initial Report FDA Received Date: 09/17/2025
• Supplement Report FDA Received Date: 11/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/19/2025
• 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