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

Model Number	M00515220
Medical Device Problem Codes	Difficult to Open or Close (2921); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.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 biopsy forceps was used in the airway during an endobronchial ultrasound (ebus) procedure performed on an unknown date.During preparation, the jaws of the forceps was found stuck in an open position and unable to close.The procedure was completed using an alternate device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: imdrf device code a051104 captures the reportable event of jaws failure to close.Block h2: block b5 has been updated based on additional information received on july 17, 2025.
Event or Problem Description
It was reported to boston scientific corporation that a coredx biopsy forceps was used in the airway during an endobronchial ultrasound (ebus) procedure performed on an unknown date.During preparation, the jaws of the forceps was found stuck in an open position and unable to close.The procedure was completed using an alternate device.There were no patient complications as a result of this event.Additional information received on july 17, 2025.The procedure was completed with another coredx forceps.
Event or Problem Description
It was reported to boston scientific corporation that a coredx biopsy forceps was used in the airway during an endobronchial ultrasound (ebus) procedure performed on an unknown date.During preparation, the jaws of the forceps was found stuck in an open position and unable to close.The procedure was completed using an alternate device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: imdrf device code a051104 captures the reportable event of jaws failure to close.Block h11: the returned coredx biopsy forceps was analyzed, and it was found during visual and microscope inspection that the jacket was kinked, also the links were detached.The reported problem of jaws failure to close was confirmed.Based on all available information, the failures of jacket kinked and links detached could be caused by operational factors such as the technique used for the device manipulation.Additionally, the device probably could have suffered the damage during inspection if it was not done carefully, or if excessive force was applied when the spool was slid.Therefore, the investigation conclusion code of this event is "adverse event related to procedure" since the adverse events occurred during the procedure and the device had no influence on event.
Additional Manufacturer Narrative
Block e1 initial reporter email has been updated based on the additional information obtained on november 14, 2025.Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: imdrf device code a051104 captures the reportable event of jaws failure to close.Block h11: the returned coredx biopsy forceps was analyzed, and it was found during visual and microscope inspection that the jacket was kinked, also the links were detached.The reported problem of jaws failure to close was confirmed.Based on all available information, the failures of jacket kinked and links detached could be caused by operational factors such as the technique used for the device manipulation.Additionally, the device probably could have suffered the damage during inspection if it was not done carefully, or if excessive force was applied when the spool was slid.Therefore, the investigation conclusion code of this event is "adverse event related to procedure" since the adverse events occurred during the procedure and the device had no influence on event.
Event or Problem Description
It was reported to boston scientific corporation that a coredx biopsy forceps was used in the airway during an endobronchial ultrasound (ebus) procedure performed on an unknown date.During preparation, the jaws of the forceps was found stuck in an open position and unable to close.The procedure was completed using an alternate device.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: 22500840
• Report Number: 3005099803-2025-03206
• Device Sequence Number: 8615132
• Product Code: EOQ
• UDI-Device Identifier: 08714729971054
• UDI-Public: (01)08714729971054(17)280401(10)36214718
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/18/2025

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: 0036214718
• 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: 06/19/2025
• Supplement Date Received by Manufacturer: 07/17/2025; 08/28/2025; 11/14/2025
• Initial Report FDA Received Date: 07/14/2025
• Supplement Report FDA Received Date: 08/11/2025; 09/19/2025; 11/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/02/2025
• 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