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

Model Number	M0063901050
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: device code a0501 captures the reportable event of basket detachment.Patient code e2008 captures the reportable event of unretrieved device fragments.
Event or Problem Description
It was reported that a zero tip basket device was used during a ureteroscopy (urs) procedure.During the procedure, tone retrieval basket was advanced through a semirigid ureteroscope and deployed to capture the stone; however, a resistance was encountered during attempted withdrawal of the basket with the captured stone, and the basket broke in this attempt.Reportedly, the ureteroscope was withdrawn and a 16 fr foley catheter was placed for urinary drainage, and a guidewire was left in place via the catheter.A clear urine drainage was observed at the conclusion of the case with no patient complications.
Additional Manufacturer Narrative
Block h2: additional information: block a1, a2, a3a, a3b, a4, and block b5.Block h6: device code a0501 captures the reportable event of basket detachment.Patient code e2008 captures the reportable event of unretrieved device fragments.
Event or Problem Description
It was reported that a zero tip basket device was used during a ureteroscopy (urs) procedure.During the procedure, stone retrieval basket was advanced through a semirigid ureteroscope and deployed to capture the stone; however, a resistance was encountered during attempted withdrawal of the basket with the captured stone, and the distal end of the basket broke off in this attempt.Reportedly, the ureteroscope was withdrawn and a 16 fr foley catheter was placed for urinary drainage, and a guidewire was left in place via the catheter.Additionally, the procedure was aborted, and the broken piece was retrieved the next day by breaking up the stone with a laser and then removed using a grasper.A clear urine drainage was observed at the conclusion of the case 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; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 24562929
• Report Number: 2124215-2026-13264
• Device Sequence Number: 21215194
• Product Code: FFL
• UDI-Device Identifier: 08714729469643
• UDI-Public: (01)08714729469643(17)271030(10)37839700
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M0063901050
• Device Catalogue Number: M0063901050
• Device Lot Number: 0037839700
• 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: 02/12/2026
• Supplement Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 03/10/2026
• Supplement Report FDA Received Date: 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/30/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 21 YR
• Patient Sex: Male
• Patient Weight: 87 KG