MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTERLOCK?-35; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	M001363610
Medical Device Problem Codes	Failure to Advance (2524); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for analysis.It was observed that only the main coil was returned.Visual examination identified that the main coil was bent and stretched at the primary coil section, and the arm coil was detached.The measurable coil dimensions were inspected and compared against the applicable drawings: assy,.035 interlock 2d coil, primary coil winding specification, and coil arm, bsc.
Event or Problem Description
Reportable based on the device analysis completed on 19dec2025.It was reported that unable to advance in catheter occurred.A 10mm x 40cm interlock.035 embolics was selected for use.During the procedure, the coil became stuck inside the catheter.The procedure was completed.There were no patient complications as a result of this event.However, device analysis revealed arm coil was detached.

• Brand Name: INTERLOCK?-35
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 24079774
• Report Number: 2124215-2026-02734
• Device Sequence Number: 5878975
• Product Code: KRD
• UDI-Device Identifier: 08714729793168
• UDI-Public: (01)08714729793168(17)270921(10)34899745
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K133208
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/15/2026

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: M001363610
• Device Catalogue Number: M001363610
• Device Lot Number: 0034899745
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2025
• Initial Report FDA Received Date: 01/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/21/2024
• 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