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

Model Number	M00515220
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a180104 captures the reportable event of foreign material present in device.
Event or Problem Description
It was reported to boston scientific corporation that a coredx? was unpacked for a bronchoscopy procedure on (b)(6) 2026.During preparation, the package was opened and nurse noticed a red residue on the distal end of the forceps.They decided to open another package that did not have the same residue to use for the procedure.There were no patient complications as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that a coredx was unpacked for a bronchoscopy procedure on (b)(6) 2026.During preparation, the package was opened and nurse noticed a red residue on the distal end of the forceps.They decided to open another package that did not have the same residue to use for the procedure.There were no patient complications as a result of this event.***additional information received on january 30, 2026*** the packaging was sealed and there was no other evidence of residue.
Additional Manufacturer Narrative
Block h6: imdrf device code a180104 captures the reportable event of foreign material present in device.Block h2: additional information- block b5 has been updated based on the additional information received on january 30, 2026.Block h11: the device was not returned analysis.During the media inspection it was found that the picture provided the distal end cannot be seen clearly.Based on all available information, the reported issue "device foreign material present in device" could not be confirmed.The product was not returned for analysis to identify any defect with the device.The customer provided a picture where it can be observed that when appears to be holding the device, but the mentioned defect is not clearly visible.Without proper evaluation of the device, it remains unknown the most probable causes that contributed to the event.Additionally, based on the most relevant information for the complaint including product record review results, the device meets all manufacturing specifications required and passed all the controls and inspections, no abnormalities were reported during the assembly process.The most probable cause of the reported issues cannot be established due to lack of evidence.All compiled information on this investigation determines that the most probable cause is "unable to exclude device problem".

• 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: 24223403
• Report Number: 3005099803-2026-00372
• Device Sequence Number: 8085594
• Product Code: EOQ
• UDI-Device Identifier: 08714729971054
• UDI-Public: (01)08714729971054(17)280831(10)37341702
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 02/20/2026

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: 0037341702
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2026
• Supplement Date Received by Manufacturer: 01/30/2026
• Initial Report FDA Received Date: 01/30/2026
• Supplement Report FDA Received Date: 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2025
• 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