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

Model Number	M0063901050
Medical Device Problem Codes	Nonstandard Device (1420); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a zero tip basket device during a percutaneous coronary intervention (pci) procedure.During the procedure, the entire basket break and detached.Reportedly, it was retrieved using another basket.The procedure was completed with another of the same device with no patient complications.
Additional Manufacturer Narrative
Blocks d4, h4: 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.Block h6: device code a0501 captures the reportable event of basket detachment.Impact code f23 captures the reportable event of unexpected medical intervention.
Event or Problem Description
It was reported that a zero tip basket device during a retrograde intrarenal surgery (rirs) procedure.During the procedure, the entire basket break and detached.Reportedly, it was retrieved using another basket.The procedure was completed with another of the same device with no patient complications.
Additional Manufacturer Narrative
Blocks d4, h4: 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.Block h6: device code a0501 captures the reportable event of basket detachment.Impact code f23 captures the reportable event of unexpected medical intervention.Block h11: investigation results: the returned zero tip basket was analyzed, and it was noted that the handle returned in good conditions.It was also noted that the basket returned detached from the sheath.Microscopic examination was performed under magnification, and it was noticed that the sheath was buckled in the middle section of the device.With all the available information, boston scientific concludes that the reported event of was confirmed.However, the investigation findings did not lead to a clear conclusion about the cause of this problem.Additionally, the manufacturing process, includes different inspections to ensure that all finished devices meet specifications.Since the device was received already open, it is not possible to determine if the problem was caused due to incorrect use of the product.All the information gathered demonstrates that the cause of the event was not manufacturing related.The observed findings of sheath bucked in the device 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 lead to this condition.Taking all available information into consideration an investigation conclusion code of cause linked to device but unable to trace more specifically was assigned to this investigation since the findings do not lead to a clear conclusion about the cause of the reported adverse 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: 24184914
• Report Number: 2124215-2026-04555
• Device Sequence Number: 13142702
• Product Code: FFL
• UDI-Device Identifier: 08714729469643
• UDI-Public: (01)08714729469643
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 03/10/2026

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/28/2025
• Supplement Date Received by Manufacturer: 02/11/2026
• Initial Report FDA Received Date: 01/26/2026
• Supplement Report FDA Received Date: 03/10/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male