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	06/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Note: this report pertains to the second of two coredx biopsy forceps used during the same procedure.It was reported to boston scientific corporation that a coredx biopsy forceps was used during a procedure performed on (b)(6) 2024.During the procedure, two forceps were stuck in open position and were unable to close with the handle.The first biopsy forceps failed to close after first sample and the second forceps failed to close after four sample attempts.No further information obtained despite good faith efforts.
Additional Manufacturer Narrative
Block h6: imdrf device code a051104 captures the reportable event of jaws difficult to open or close.
Additional Manufacturer Narrative
Block b5: updated event description.Block h2: correction: information received on july 26, 2024, that this report is a duplicate sent in error.Please refer to mfr.Report #3005099803-2024-03020.Block h6: imdrf device code a051104 captures the reportable event of jaws difficult to open or close.
Event or Problem Description
Note: this report pertains to the second of two coredx biopsy forceps used during the same procedure.It was reported to boston scientific corporation that a coredx biopsy forceps was used during a procedure performed on (b)(6) 2024.During the procedure, two forceps were stuck in open position and were unable to close with the handle.The first biopsy forceps failed to close after first sample and the second forceps failed to close after four sample attempts.No further information obtained despite good faith efforts.***information received on july 26, 2024*** information was received that this event is a duplicate.See mfr.Report #3005099803-2024-03020.

• 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: 19838194
• Report Number: 3005099803-2024-03567
• Device Sequence Number: 6598213
• Product Code: EOQ
• UDI-Device Identifier: 08714729971054
• UDI-Public: 08714729971054
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 08/16/2024

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2024
• Supplement Date Received by Manufacturer: 07/26/2024
• Initial Report FDA Received Date: 07/26/2024
• Supplement Report FDA Received Date: 08/20/2024
• 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