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
Event or Problem Description
It was reported to boston scientific corporation that a coredx pulmonary forceps was used in the lungs during an endoscopic ultrasound-guided lymph node biopsy needle aspiration procedure on (b)(6) 2025.During the procedure, when the forceps were opened, a wire popped out from the inside making biopsy impossible.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.
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 jacket had evidence of a mechanical cut, the links were detached, clevis arms were bent, and the pull wire attachment was dislocated.The reported event of pull wire break was confirmed.Based on the available information, the investigation findings were procedural factors as lesion characteristics, handling of the device, the technique used by the physician, and normal procedural difficulties encountered during the procedure could have resulted in the observed damages in the device, once the links detach the jaws failure became unable to close during procedure.It is possible that factors and/or conditions related to procedure during the use of the device could have affected its performance and its intended purpose, leading to the reported event, and probably since the jaws won't close the physician cut the jacket to remove the device from the scope to avoid damage it.Therefore, a review and analysis of all available information indicated the most probable cause 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 an endoscopic ultrasound-guided lymph node biopsy needle aspiration procedure on (b)(6) 2025.During the procedure, when the forceps were opened, a wire popped out from the inside making biopsy impossible.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: 23076077
• Report Number: 3005099803-2025-04742
• Device Sequence Number: 4644817
• Product Code: EOQ
• UDI-Device Identifier: 08714729971054
• UDI-Public: (01)08714729971054(17)280205(10)35778267
• 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): 11/13/2025

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: 0035778267
• 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: 11/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/05/2025
• 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