MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AccuStick II; introducer, catheter

Model Number	35615
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the microwire fractured, requiring additional intervention.During placement of a left renal abscess drain, an accustick ii system was selected for use.While manipulating the microwire, a portion of the microwire sheared off and remained within the patient.Because infected urine was present, only minimal retrieval attempts were made during the initial procedure.Nine days later, the patient returned for percutaneous retrieval of the retained wire fragment during removal of the indwelling abscess drain.Retrieval using a snare was unsuccessful, and the retained fragment could not be removed percutaneously.Further management with retrograde ureteroscopy or surgery was recommended if clinically indicated.The patient was expected to fully recover, and no patient complications were reported as a result of this event.
Event or Problem Description
It was reported that the microwire fractured, requiring additional intervention.During placement of a left renal abscess drain, an accustick ii system was selected for use.While manipulating the microwire, a portion of the microwire sheared off and remained within the patient.Because infected urine was present, only minimal retrieval attempts were made during the initial procedure.Nine days later, the patient returned for percutaneous retrieval of the retained wire fragment during removal of the indwelling abscess drain.Retrieval using a snare was unsuccessful, and the retained fragment could not be removed percutaneously.Further management with retrograde ureteroscopy or surgery was recommended if clinically indicated.The patient was expected to fully recover, and no patient complications were reported as a result of this event.
Additional Manufacturer Narrative
Correction to h6 evaluation method codes media review: media was provided and reviewed, but it does not show evidence of the reported issue.Device history records (dhr) review: a ship history review for the reported upn was performed for the reporting customer.Batches (38686694), (38614720), and (37679258) were most recently shipped to the reporting facility in the 3-year period preceding the procedure date.Review confirmed that the device met all material, assembly, and performance specifications prior to distribution labeling review: review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Risk review: a risk review performed for the accustick device confirmed that the reported event is a known event defined in the product's risk management documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefits for the product investigation conclusion: based on a thorough review of the reported complaint, the most probable cause for this complaint was cause not established.

• Brand Name: AccuStick II
• Common Device Name: introducer, catheter
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): Boston Scientific Corporation; 300 boston scientific way; marlborough MA
• Manufacturer Contact: ricardo amaro castro ; 4100 hamline ave n; arden hills, MN 55112 ; +1(952)930-6396
• MDR Report Key: 25847611
• Report Number: 2124215-2026-38327
• Device Sequence Number: 13370704
• Product Code: KGZ
• UDI-Device Identifier: 08714729157588
• UDI-Public: (01)08714729157588
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/22/2026

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: 35615
• Device Catalogue Number: 35615
• 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: 06/18/2026
• Supplement Date Received by Manufacturer: 07/21/2026; 08/24/2026
• Initial Report FDA Received Date: 07/16/2026
• Supplement Report FDA Received Date: 08/14/2026; 09/22/2026
• 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 Sex: Unknown