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

Model Number	M00515220
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event, as no event date was reported.Block d4, h4: detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete udi and other product specific information.If additional details become available, a supplemental report will be submitted.Block h6: imdr device code a0501 captures the reportable event of jaws detached.Imdr device code f2301 captures the reportable event of additional device required.
Event or Problem Description
It was reported to boston scientific corporation that a coredx pulmonary mini biopsy forceps were used during a procedure on an unknown date.During the procedure, the mini forceps broke off in the pulmonology scope.The piece that broke off was retrieved with a new scope.Two sets of mini forceps broke while inside the patient.It was unknown how the procedure was completed and if there were any reported patient complication as a result of this event.Note: this report pertains to the first of two coredx pulmonary mini biopsy forceps used during the same procedure.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event, as no event date was reported.Block d4, h4: detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete udi and other product specific information.If additional details become available, a supplemental report will be submitted.Block h6: imdr device code a0501 captures the reportable event of jaws detached.Imdr device code f2301 captures the reportable event of additional device required.Block h11: based on the available information, boston scientific could not confirm the reported event of jaws detachment of device or device component.The device was not returned for analysis; therefore, a technical analysis could not be performed.It was confirmed that this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Based on the event description and information provided by the customer there is not enough evidence to determine whether the event was due to the physician's technique during the procedure or was related to a device malfunction.Based on all available information, boston scientific has assigned an investigation conclusion code of cause not established.
Event or Problem Description
It was reported to boston scientific corporation that a coredx pulmonary mini biopsy forceps were used during a procedure on an unknown date.During the procedure, the mini forceps broke off in the pulmonology scope.The piece that broke off was retrieved with a new scope.Two sets of mini forceps broke while inside the patient.It was unknown how the procedure was completed and if there were any reported patient complication as a result of this event.No further information has been obtained despite good faith efforts.Note: this report pertains to the first of two coredx pulmonary mini biopsy forceps used during the same procedure.

• 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: 24663019
• Report Number: 3005099803-2026-01052
• Device Sequence Number: 18452550
• Product Code: EOQ
• UDI-Device Identifier: 08714729971054
• UDI-Public: (01)08714729971054
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M00515220
• Device Catalogue Number: M00515220
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2026
• Supplement Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 03/23/2026
• Supplement Report FDA Received Date: 04/17/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown