MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ZERO TIP; BRONCHOSCOPE ACCESSORY

Model Number	M00513210
Medical Device Problem Codes	Break (1069); Material Twisted/Bent (2981); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1: initial reporter facility name is (b)(6) hospital.Block h6: device code a0401 captures the reportable event of basket wire break.
Event or Problem Description
It was reported to boston scientific corporation that a zero tip was used in the basal segment of the left lower lung during a fibrobronchoscopic alveolar lavage procedure performed on (b)(6) 2024.During the procedure, there was knot about 4cm away from the tip of the basket.The basket was gently removed, and it was observed broken.Another of the same device was used to complete the procedure.No patient complications were reported as a result of this event.The patient's condition at the conclusion of the procedure is reported to be stable.
Event or Problem Description
It was reported to boston scientific corporation that a zero tip was used in the basal segment of the left lower lung during a fibrobronchoscopic alveolar lavage procedure performed on (b)(6) 2024.During the procedure, there was knot about 4cm away from the tip of the basket.The basket was gently removed, and it was observed broken.Another of the same device was used to complete the procedure.No patient complications were reported as a result of this event.The patient's condition at the conclusion of the procedure is reported to be stable.
Additional Manufacturer Narrative
Block e1: initial reporter facility name is (b)(6).Block h6: device code a0401 captures the reportable event of basket wire break.Block h2: block a1 (patient identifier) and e1 (initial reporter address 1, initial reporter address 2, and initial reporter city) have been updated based on additional information received on 23dec2024.
Event or Problem Description
It was reported to boston scientific corporation that a zero tip was used in the basal segment of the left lower lung during a fibrobronchoscopic alveolar lavage procedure performed on (b)(6) 2024.During the procedure, there was knot about 4cm away from the tip of the basket.The basket was gently removed, and it was observed broken.Another of the same device was used to complete the procedure.No patient complications were reported as a result of this event.The patient's condition at the conclusion of the procedure is reported to be stable.
Additional Manufacturer Narrative
E1: initial reporter facility name is (b)(6) hospital.H6: device code a0401 captures the reportable event of basket wire break.H11: the returned zero tip was analyzed, and a visual inspection found the sheath from the working length was detached, twisted, and kinked.The basket wires were kinked, and one of them were detached.The reported event that the basket wire broke was confirmed.Based on all available information, it is most likely that the damages seen during the product analysis happened as a result of the manipulation of the device inside the patient by the physician's technique.Therefore, the most probable root cause is adverse event related to procedure.

• Brand Name: ZERO TIP
• Common Device Name: BRONCHOSCOPE ACCESSORY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 20910745
• Report Number: 3005099803-2024-06341
• Device Sequence Number: 7778691
• Product Code: KTI
• UDI-Device Identifier: 08714729415008
• UDI-Public: 08714729415008
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K020765
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/03/2025

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: 07/21/2025
• Device Model Number: M00513210
• Device Catalogue Number: M00513210
• Device Lot Number: 0029811910
• 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: 11/22/2024
• Supplement Date Received by Manufacturer: 12/23/2024; 02/03/2025
• Initial Report FDA Received Date: 12/12/2024
• Supplement Report FDA Received Date: 01/17/2025; 03/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2022
• 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 Age: 7 YR
• Patient Sex: Male
• Patient Weight: 21 KG