MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ACCUSTICK II; INTRODUCER, CATHETER

Model Number	35615
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter facility name: (b)(6).The device was not returned for analysis since it was discarded at facility.A media image was received from the reporter that revealed the wire was kinked, but was not able to confirm the reported detachment.
Event or Problem Description
It was reported that hub detachment occurred.A accustick ii was selected for use.During the procedure, it was noted that the wire got broken.The device was removed and the procedure was completed with an alternate device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
E1: initial reporter facility name: (b)(6).The device was not returned for analysis since it was discarded at facility.A media image was received from the reporter that revealed the wire was kinked, but was not able to confirm the reported detachment.H6: device codes: updated.H6: component codes: updated.H6: evaluation method codes: updated.H6: evaluation result codes: updated.
Event or Problem Description
It was reported that hub detachment occurred.A accustick ii was selected for use.During the procedure, it was noted that the wire got broken.The device was removed and the procedure was completed with an alternate device.There were no patient complications as a result of this event.

• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 24070324
• Report Number: 2124215-2026-02528
• Device Sequence Number: 13328675
• Product Code: KGZ
• UDI-Device Identifier: 08714729201137
• UDI-Public: (01)08714729201137(17)280421(10)36348088
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 02/11/2026

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: 0036348088
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2025
• Supplement Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 01/14/2026
• Supplement Report FDA Received Date: 02/11/2026
• Date Device Manufactured: 04/22/2025
• 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
• Patient Sex: Unknown