MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CoreDx¿; Bronchoscope (Flexible Or Rigid)

Model Number	M00515220
Medical Device Problem Codes	Entrapment of Device (1212); 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	06/03/2026
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 pulmonary mini biopsy forceps was used in the lungs during a bronchoscopy procedure performed on (b)(6) 2026.During the procedure, the forceps became stuck in the open position and could not be closed or withdrawn through the endoscope working channel.As a result, the forceps and endoscope were removed together, and the device was cut off.The procedure was completed using another coredx device.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that a coredx pulmonary mini biopsy forceps was used in the lungs during a bronchoscopy procedure performed on (b)(6) 2026.During the procedure, the forceps became stuck in the open position and could not be closed or withdrawn through the endoscope working channel.As a result, the forceps and endoscope were removed together, and the device was cut off.The procedure was completed using another coredx device.There were no patient complications reported 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: investigation results: the complaint device was not returned; therefore, product analysis could not be performed.However, photographs provided by the customer show that the distal section of the device is detached, with the separation appearing consistent with a mechanical cut.The jaws also show evidence of uneven opening.It was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.A similar complaint review was completed.There were no emerging trends identified that warrant further action.Based on the event description and information provided by the customer, there is not enough evidence to determine whether the reported events jaws failure to close, jaws uneven opening, device entrapment of device or device component, and additional device required were related to physician technique, procedural factors, or a potential device malfunction.Although the reported event jaws uneven opening can be confirmed based on the available photo evidence, and the device distal section is observed detached, it is not possible to determine whether these observations are related to the reported mechanism of failure, as the device was not returned for evaluation and no physical analysis could be performed.All compiled information on this investigation determines that the most probable cause is cause not established.

• 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 ; +1(914)571-6918
• MDR Report Key: 25682424
• Report Number: 3005099803-2026-02638
• Device Sequence Number: 13175779
• Product Code: EOQ
• UDI-Device Identifier: 08714729971054
• UDI-Public: (01)08714729971054(17)290420(10)39144683
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K183085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 08/27/2026

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: 0039144683
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2026
• Supplement Date Received by Manufacturer: 07/31/2026
• Initial Report FDA Received Date: 07/01/2026
• Supplement Report FDA Received Date: 08/28/2026
• Date Device Manufactured: 04/21/2026
• 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