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

Model Number	35615
Medical Device Problem Codes	Nonstandard Device (1420); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/22/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional patient details were not provided to bsc.We completed a good faith effort to obtain the information, but it was unable to be obtained.If additional details become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that distal tip detachment occurred and remained inside the patient.The vascular access was through the left hepatic duct.A 0.038 j accustick ii was selected for use in a percutaneous transhepatic cholangiography (ptc) with placement of left internal/external biliary drain.Upon access into the biliary tree and during manipulation of the wire, it was discovered that the wire had kinked.Consequently, the distal tip sheared off during continued manipulation.The tip remained in the biliary system and was not retrieved.

• 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; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: ricardo amaro castro ; 4100 hamline ave n; arden hills, MN 55112 ; +1(952)930-6396
• MDR Report Key: 25186854
• Report Number: 2124215-2026-26392
• Device Sequence Number: 21406407
• Product Code: KGZ
• UDI-Device Identifier: 08714729157588
• UDI-Public: (01)08714729157588(17)290119(10)38394069
• 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,Followup
• Report Date (Section B): 10/02/2026

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: 35615
• Device Catalogue Number: 35615
• Device Lot Number: 0038394069
• 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: 04/23/2026
• Supplement Date Received by Manufacturer: 05/18/2026; 09/10/2026
• Initial Report FDA Received Date: 05/15/2026
• Supplement Report FDA Received Date: 06/10/2026; 10/02/2026
• Date Device Manufactured: 01/20/2026
• 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: Other
• Patient Age: 68 YR
• Patient Sex: Female