MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Zero Tip; Dislodger, Stone, Basket, Ureteral, Metal

Model Number	M0063901050
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block b3: date of event was approximated to 10/01/2025 based on the date the manufacturer became aware of the event.Block h6: device code a020504 captures the reportable event of hole in the packaging.The product packaging was not received for analysis; therefore, no physical analysis of the product packaging could be performed.The reported allegation cannot be confirmed.The device history record review confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Based on the information available the cause that contributed to the reported event cannot be established.
Event or Problem Description
It was reported that the plastic around the zero tip basket device had a hole in it, down towards the bottom, making it non-sterile.There were no patient and procedure involved.

• 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: 24283313
• Report Number: 2124215-2026-07001
• Device Sequence Number: 18607427
• Product Code: FFL
• UDI-Device Identifier: 08714729469643
• UDI-Public: (01)08714729469643(17)270830(10)37333984
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2026

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 Model Number: M0063901050
• Device Catalogue Number: M0063901050
• Device Lot Number: 0037333984
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2026
• Supplement Date Received by Manufacturer: 07/13/2026
• Initial Report FDA Received Date: 02/06/2026
• Supplement Report FDA Received Date: 08/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2025
• 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