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

Model Number	M00515220
Medical Device Problem Codes	Break (1069); 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	08/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a coredx biopsy forceps was attempted to be used in the pulmonary submucosal lymph nodes during a endoscopic ultrasound-guided lymph node biopsy procedure performed on (b)(6) 2024.During the procedure, the wire for opening and closing the cup was detached making it impossible to open and close.When the handle was operated, the wire tip would only protrude or retract.The procedure was not completed successfully.
Additional Manufacturer Narrative
Block h6: imdrf device code a051104 captures the reportable event of jaws failure to close.
Additional Manufacturer Narrative
Block h6: imdrf device code a051104 captures the reportable event of jaws failure to close.Block h11: investigation results: the returned coredx biopsy forceps was received for analysis.Visual examination revealed that the jacket had evidence of a mechanical cut.The links were detached.The pull wires were not broken.A function evaluation could not be performed due to the condition of the device.The reported event of jaws failure to open was confirmed.Based on the available information, the investigation findings were most likely generated due to device manipulation.During the procedure an excess of force could have been applied when inserting through another device or when interacting with the scope.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that a coredx biopsy forceps was attempted to be used in the pulmonary submucosal lymph nodes during an endoscopic ultrasound-guided lymph node biopsy procedure performed on (b)(6) 2024.During the procedure, the wire for opening and closing the cup was detached making it impossible to open and close.When the handle was operated, the wire tip would only protrude or retract.The procedure was not completed successfully.

• 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 20224618
• Report Number: 3005099803-2024-04475
• Device Sequence Number: 7315053
• Product Code: EOQ
• UDI-Device Identifier: 08714729971054
• UDI-Public: 08714729971054
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2024

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: 55458
• Device Lot Number: 0033469136
• 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: 08/23/2024
• Supplement Date Received by Manufacturer: 10/17/2024
• Initial Report FDA Received Date: 09/16/2024
• Supplement Report FDA Received Date: 11/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2024
• 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