MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ZERO TIP; DISLODGER, STONE, BASKET, URETERAL, METAL

Model Number	M0063901010
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of basket wire detached.
Event or Problem Description
It was reported to boston scientific corporation that a zero tip basket device was used during a ureteroscopic lithotripsy (ursl) procedure performed on (b)(6) 2023.During the procedure, basket wire and the handle completely detached.The pieces were removed upon separation.The procedure was completed with another zero tip basket device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of basket wire detached.Block h10: investigation results the returned zero tip basket was analyzed, and a visual evaluation noted that the cannula and sheath returned detached from the handle.It was also noted that the basket was slightly extended and there is no evidence of basket wires broken.With all available information, boston scientific concludes that the reported event of basket wire break is not confirmed the since condition of the device does not let to perform a functional inspection.Based on the investigation results this could be related to handling and manipulation of the device during procedure, it is probable that an excess of force applied to the device such as operational factors during their use could lead to cause the detachment of the cannula and sheath from the handle.Also, instruction for use (ifu) emphasizes that if resistance is encountered during advancement or withdrawal of the device, do not exert excessive force.Based on the investigation results, the most probable cause of adverse event related to procedure was assigned to this investigation.
Event or Problem Description
It was reported to boston scientific corporation that a zero tip basket device was used during a ureteroscopic lithotripsy (ursl) procedure performed on (b)(6) 2023.During the procedure, basket wire and the handle completely detached.The pieces were removed upon separation.The procedure was completed with another zero tip basket device.There were no patient complications reported as a result of this event.

• Brand Name: ZERO TIP
• Common Device Name: DISLODGER, STONE, BASKET, URETERAL, METAL
• 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: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 18528300
• Report Number: 2124215-2024-01716
• Device Sequence Number: 6383151
• Product Code: FFL
• UDI-Device Identifier: 08714729342007
• UDI-Public: 08714729342007
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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): 03/01/2024

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: 12/12/2025
• Device Model Number: M0063901010
• Device Catalogue Number: 390-101
• Device Lot Number: 0030703090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/28/2023
• Supplement Date Received by Manufacturer: 02/09/2024
• Initial Report FDA Received Date: 01/17/2024
• Supplement Report FDA Received Date: 03/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2022
• 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 Sex: Unknown