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

Model Number	M001361500
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	03/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter facility name: (b)(6).The device was returned for analysis, and upon inspection, it was noted that only the main coil had been returned.Visual and microscopic inspection revealed the main coil was bent and stretched at the coil arm and primary coil section.Additionally, the arm coil was found to be detached.Dimensional inspections of the main coil were within specification.
Event or Problem Description
Reportable based on the device analysis completed on 12jun2025.It was reported that the coil was unable to advance.The stenosed target lesion was identified in the liver.A 3mm x 6cm interlock device was chosen for the procedure.The patient subsequently underwent tumor hemorrhagic embolization.During the procedure, the second coil could not be pushed out in the protective sheath.Despite multiple attempts, the coil still could not be pushed out.The procedure was completed using two of the same coils.There were no patient complications as a result of this event.The patient status post procedure was stable.However, returned device analysis revealed main coil was detached.

• Brand Name: INTERLOCK?
• 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: 22469946
• Report Number: 2124215-2025-44808
• Device Sequence Number: 20818338
• Product Code: KRD
• UDI-Device Identifier: 08714729764939
• UDI-Public: (01)08714729764939(17)261105(10)33001030
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K132578
• 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
• Report Date (Section B): 07/10/2025

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: M001361500
• Device Catalogue Number: M001361500
• Device Lot Number: 0033001030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2025
• Initial Report FDA Received Date: 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MICROCATHETER: BSC STC-18.
• Patient Age: 46 YR
• Patient Sex: Male
• Patient Weight: 64 KG