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

Model Number	M0063901050
Medical Device Problem Codes	Break (1069); Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a zero tip basket device was use during a procedure.Reportedly, one of the basket wires broke; however, analysis of the returned device revealed that one of the basket wires break and fully detached from the basket.
Additional Manufacturer Narrative
Block h6: device code a0401 captures the reportable investigation result of basket wire detached.Block h11: investigation results the returned zero tip basket was analyzed, and a visual evaluation noted that the handle returned in good condition.It was also noted that the device returned with the basket on its open position.Microscopic examination was performed under magnification, and it was noticed that one of the basket wires was broken and fully detached.Additionally, the sheath was kinked and stretched.With all the available information, boston scientific concludes that the reported event confirmed.Based on the analysis results, these 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 cause the damages observed in the device.During the manufacturing process, a final inspection ensures the integrity and functionality of the device that would have captured the problems found.Taking all available information into consideration, an investigation conclusion code of adverse event related to procedure was assigned to this investigation since the adverse events occurred during the procedure and the device had no influence on the 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; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 23897640
• Report Number: 2124215-2025-93171
• Device Sequence Number: 17416367
• Product Code: FFL
• UDI-Device Identifier: 08714729469643
• UDI-Public: (01)08714729469643(17)260427(10)33917767
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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
• Report Date (Section B): 12/26/2025

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: 04/27/2026
• Device Model Number: M0063901050
• Device Catalogue Number: M0063901050
• Device Lot Number: 0033917767
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 12/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/27/2024
• 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