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

Model Number	M00515220
Medical Device Problem Codes	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	06/03/2024
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
Note: this report pertains to one of two different core dx devices used in the same procedure.It was reported to boston scientific corporation that a coredx biopsy forceps was used in the ln7 during a bronchoscopy procedure performed on (b)(6) 2024.During procedure, the cups failed to close and had uneven opening.A second coredx biopsy forceps was tried and the same problem happened.The procedure was completed with a third coredx biopsy forceps.There were no patient complications as a result of this event.Note: a photo and video of the device outside the patient was provided showing the jaws with uneven opening and failing to close.
Additional Manufacturer Narrative
Block h2 (additional information): blocks d4, e1, e2, e3, h4 and h10 were updated based on the additional information received on july 26, 2024.Block h11: imdrf device code a051104 captures the reportable event of jaws failure to close.
Event or Problem Description
Note: this report pertains to one of two different core dx devices used in the same procedure.It was reported to boston scientific corporation that a coredx biopsy forceps was used in the ln7 during a bronchoscopy procedure performed on (b)(6) 2024.During procedure, the cups failed to close and had uneven opening.A second coredx biopsy forceps was tried and the same problem happened.The procedure was completed with a third coredx biopsy forceps.There were no patient complications as a result of this event.Note: a photo and video of the device outside the patient was provided showing the jaws with uneven opening and failing to close.
Additional Manufacturer Narrative
Block h2 (additional information): blocks d4, e1, e2, e3, h4 and h10 were updated based on the additional information received on july 26, 2024.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 and microscope inspection revealed that one link was detached from the core wire attachment.Due to this condition the jaws were unable to open and close.Media analysis of a video provided by the account also showed the device being unable to open and close.The reported event was confirmed.Based on the available information, the investigation finding of link detached was most likely generated due to procedural factors such as lesion characteristics, handling of the device, the technique used by the physician, or normal procedural difficulties.Therefore, it is possible that factors and/or conditions related to procedure during the use of the device could have affected its performance and its intended purpose, leading to the reported event.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to procedure.A product labeling review identified that the device was used per the directions for use (dfu)/product label.
Event or Problem Description
Note: this report pertains to one of two different core dx devices used in the same procedure.It was reported to boston scientific corporation that a coredx biopsy forceps was used in the ln7 during a bronchoscopy procedure performed on (b)(6) 2024.During procedure, the cups failed to close and had uneven opening.A second coredx biopsy forceps was tried and the same problem happened.The procedure was completed with a third coredx biopsy forceps.There were no patient complications as a result of this event.Note: a photo and video of the device outside the patient was provided showing the jaws with uneven opening and failing to close.

• 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: 19633247
• Report Number: 3005099803-2024-03020
• Device Sequence Number: 18341349
• Product Code: EOQ
• UDI-Device Identifier: 08714729971054
• UDI-Public: 08714729971054
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: CA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/22/2024

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 Expiration Date: 09/03/2026
• Device Model Number: M00515220
• Device Catalogue Number: 55458
• Device Lot Number: 0032353641
• 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: 06/04/2024
• Supplement Date Received by Manufacturer: 07/26/2024; 09/26/2024
• Initial Report FDA Received Date: 06/28/2024
• Supplement Report FDA Received Date: 08/22/2024; 10/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/04/2023
• 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