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	05/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h11: 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 biopsy forceps was used in the lymph node of the lungs during a biopsy procedure performed on (b)(6) 2024.During insertion, when actuating the handle, a cracking sound was noted, and the cups could no longer close.Another coredx was used to complete 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 biopsy forceps was used in the lymph node of the lungs during a biopsy procedure performed on (b)(6) 2024.During insertion, when actuating the handle, a cracking sound was noted, and the cups could no longer close.Another coredx was used to complete the procedure.There were no patient complications 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: the returned coredx forceps was analyzed, and a visual and microscope inspection observed the device had residues from the procedure.The links were observed detached, and one of the jaws was bent.A functional test could not be performed due to the device condition.Based on all available information, the observed issues could have occurred due to excess manipulation.It is most likely that excess force applied to the device such as insertion through another device or interaction with the scope, caused the damages observed.These conditions limited the overall performance of the device, making the jaws unable to close.The bent jaw could have been generated if the jaws were open during insertion.Any contact with the scope could also bend the jaws.Once the jaws are bent, they could get stuck and any attempt to operate the device can cause the links to detach.Therefore, the most probable root cause is adverse event related to 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 19587270
• Report Number: 3005099803-2024-02948
• Device Sequence Number: 7392316
• 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): 08/27/2024

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: 0033561378
• 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: 05/28/2024
• Supplement Date Received by Manufacturer: 08/01/2024
• Initial Report FDA Received Date: 06/21/2024
• Supplement Report FDA Received Date: 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/05/2024
• 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