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

Model Number	M00515220
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a coredx pulmonary forceps was used during bronchoscopy procedure on an unknown date.During the procedure, the forceps malfunctioned and could not be used to obtain a sample due to the jaws not closing once opened.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 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 complaint device was not returned therefore, product analysis could not be performed, for this reason and due to the lack of evidence is unable to confirm the reported event.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.A risk review was completed and confirmed that the event of "jaws failure to close" was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.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 jaws failure to close were due to the physician's manipulation/technique during the procedure or related to a device malfunction, cause not established is selected as the most probable cause for this event.Additionally, due to lack of evidence and without proper evaluation of the device, this investigation is assigned a most probable conclusion code of "cause not established" the conclusion is acceptable because of the analysis of the available information in the complaint did not determine a more specific complaint cause, in addition, without physical evaluation of the device, it remains unknown the most probable causes that contributed to the event.Also, the evidence from the product record review did not identify a potential product quality issue or new patient harm.

• 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: 25884309
• Report Number: 3005099803-2026-02958
• Device Sequence Number: 10017541
• Product Code: EOQ
• UDI-Device Identifier: 08714729971054
• UDI-Public: (01)08714729971054(17)290420(10)39144683
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: 06/25/2026
• Supplement Date Received by Manufacturer: 07/31/2026
• Initial Report FDA Received Date: 07/20/2026
• 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