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

Model Number	M00513200
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a zero tip pulmonary basket was used in the bronchus during the removal of intrabronchial foreign body procedure performed on (b)(6) 2023.During the procedure, when the basket was opened to retrieve the foreign body, the connection port between the handle and the wire fractured.The device was removed, and another zero tip pulmonary basket was used to complete the procedure.There were no patient complications reported as a result of this event.The patient's condition following the procedure was reported to be stable.
Additional Manufacturer Narrative
H6: imdrf device code a0401 captures the reportable event of handle break.E1: initial reporter address 1: (b)(6).Initial reporter phone: (b)(6).
Event or Problem Description
It was reported to boston scientific corporation that a zero tip pulmonary basket was used in the bronchus during the removal of intrabronchial foreign body procedure performed on (b)(6) 2023.During the procedure, when the basket was opened to retrieve the foreign body, the connection port between the handle and the wire fractured.The device was removed, and another zero tip pulmonary basket was used to complete the procedure.There were no patient complications reported as a result of this event.The patient's condition following the procedure was reported to be stable.
Additional Manufacturer Narrative
H6: imdrf device code a0401 captures the reportable event of handle break.E1: initial reporter address 1: (b)(6).Initial reporter phone: (b)(6).Block h10: the returned trapezoid rx basket was analyzed, and a visual evaluation observed the sheath was stretched and buckled in the proximal section.No other damages were noted.The reported event of handle break was not confirmed.Based on all available information, it is most likely that user manipulation, some technique applied during procedure, and/or anatomical factors contributed on sheath stretched and buckled.Once the sheath was damaged the user may have experienced difficulty to manipulate the device, and this could have been perceived by the physician as fracture on the connection port between the handle and the wire.Therefore, the most probable root cause is adverse event related to procedure.A labeling review was performed, and from the information available, this device was used in accordance with the instructions for use / product label.

• 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 18240218
• Report Number: 3005099803-2023-06407
• Device Sequence Number: 16950657
• Product Code: KTI
• UDI-Device Identifier: 08714729414995
• UDI-Public: 08714729414995
• 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,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2024

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: 04/10/2025
• Device Model Number: M00513200
• Device Catalogue Number: 1320
• Device Lot Number: 0029208436
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/07/2023
• Supplement Date Received by Manufacturer: 01/09/2024
• Initial Report FDA Received Date: 11/30/2023
• Supplement Report FDA Received Date: 01/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2022
• 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: 1 YR
• Patient Sex: Male
• Patient Weight: 13 KG