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

Model Number	M0063901010
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Product was removed from package and before use stone basket wires were found to be broken.

• 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
• MDR Report Key: 23485382
• Report Number: 23485382
• Device Sequence Number: 18699096
• Product Code: FFL
• UDI-Device Identifier: 08714729342007
• UDI-Public: (01)08714729342007(17)280902(10)37362792
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/28/2025
• Report Date (Section F): 10/29/2025

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
• Device Model Number: M0063901010
• Device Catalogue Number: M0063901010
• Device Lot Number: 37362792
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 1 MO
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 11/06/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/06/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 10/29/2025