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

Model Number	M0063901020
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block a2: patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Block h6: device code a0401 captures the reportable event of pull wire break.
Event or Problem Description
It was reported that a zero tip basket device was used during a ureteroscopic lithotripsy procedure.During the procedure, when using the basket, the wire suddenly broke.The procedure was completed with another of the same device with no patient complications.
Additional Manufacturer Narrative
Block a2: patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Block h6: device code a0401 captures the reportable event of pull wire break.Block h11: investigation results.The returned zero tip basket was analyzed, and a visual evaluation noted that the handle returned disassembled.It was also noted that the cannula and pull wire were out of the sheath.Media analysis shows with the picture provided by the customer that the basket with sheath torn at the proximal section.Microscopic examination was performed under magnification, and it was noticed that the basket wires returned in good condition.The pull wire returned attached to the handle cannula and to the notch cannula.Additionally, the basket attached to the notch cannula.The sheath returned stretch at the distal section and torn at the proximal, middle and distal section.The handle cannula was kinked.With all the available information, boston scientific concludes that the reported event of pull wire break was not confirmed since it was not possible to identify any evidence of the alleged issue on the device, since the pull wire returned in good conditions.The observed findings of sheath stretched at the distal section and torn at the proximal, middle and distal section, also, the handle cannula kinked 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 have led to the issues observed.Taking all available information into consideration, an investigation conclusion code of adverse event related to procedure was assigned to this investigation.
Event or Problem Description
It was reported that a zero tip basket device was used during a ureteroscopic lithotripsy procedure.During the procedure, when using the basket, the wire suddenly broke.The procedure was completed with another of the same device with no patient complications.

• 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: 21144771
• Report Number: 2124215-2025-00946
• Device Sequence Number: 15762033
• Product Code: FFL
• UDI-Device Identifier: 08714729342014
• UDI-Public: 08714729342014
• 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): 03/03/2025

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: 06/22/2026
• Device Model Number: M0063901020
• Device Catalogue Number: M0063901020
• Device Lot Number: 0031884539
• 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: 12/20/2024
• Supplement Date Received by Manufacturer: 02/05/2025
• Initial Report FDA Received Date: 01/13/2025
• Supplement Report FDA Received Date: 03/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/23/2023
• 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