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

Model Number	M0063901020
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: device code a0414 captures the reportable event of sheath torn material at distal end.Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete udi and other product specific information.If additional details become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that a zero tip basket device was used in a ureterorenoscopy and lithotripsy procedure.During preparation, it was found that the outer casing net of the device has burrs.The procedure was completed with another same device and there were no patient complications reported.
Event or Problem Description
It was reported that a zero tip basket device was used in a ureterorenoscopy and lithotripsy procedure.During preparation, it was found that the outer casing net of the device has burrs.The procedure was completed with another same device and there were no patient complications reported.
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: device code a0414 captures the reportable event of sheath torn material at distal end.Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete udi and other product specific information.If additional details become available, a supplemental report will be submitted.Upon receipt at our quality assurance laboratory, this zero tip basket underwent a thorough analysis.Visual inspection of the device identified that the sheath was torn at the distal section.The device was inspected under magnification, and it was possible to see that the sheath was kinked in the center.The handle was actuated and the basket was able to open and close.Based on the information available and analysis results, the issues found could be related to handling and manipulation of the device during preparation.It is probable that an excess of force applied to the device such as operational factors could lead to bend and kink of the sheath.A conclusion code of adverse event related to procedure was assigned to this investigation.

• 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: 22382507
• Report Number: 2124215-2025-43314
• Device Sequence Number: 9355086
• Product Code: FFL
• UDI-Device Identifier: 08714729342014
• UDI-Public: (01)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): 08/20/2025

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 Model Number: M0063901020
• Device Catalogue Number: M0063901020
• 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: 06/04/2025
• Supplement Date Received by Manufacturer: 07/24/2025
• Initial Report FDA Received Date: 07/02/2025
• Supplement Report FDA Received Date: 08/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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