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

Model Number	M001361570
Medical Device Problem Codes	Difficult to Insert (1316); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 initial reporter facility name: (b)(6).E1 initial reporter address 1: (b)(6).Device evaluation by manufacturer: the device was returned for analysis.Visual and microscopic inspection observed that the main coil, the introducer sheath and the pusher wire were returned.The main coil was bent and stretched at the coil arm and primary coil section, moreover the arm coil was detached.Additionally, the pusher wire was detached and stretched at the coil section and kinked at the heat shrink tfe tubing.Dimensional inspection was performed, and the main coil's max zap tip outer diameter (od), primary coil od, pusher wire mid solder joint od, distal tfe od and proximal tfe od were within specifications.
Event or Problem Description
Reportable based on device analysis completed on 30apr2025.It was reported that the coil could not be delivered.The target lesion was located in the hepatic artery.A 6mm x 20cm interlock coil was advanced for treatment.However, the coil became stuck at the opening of the 2.6 non-boston scientific catheter and could not be delivered out.The procedure was completed with another of the same device.There was no patient complications noted as a result of this event, and the patient condition following procedure was stable.However, returned device analysis revealed the pusher wire and arm coil were 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: 22099436
• Report Number: 2124215-2025-31912
• Device Sequence Number: 17998297
• Product Code: KRD
• UDI-Device Identifier: 08714729765004
• UDI-Public: (01)08714729765004(17)270312(10)33804722
• 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): 05/28/2025

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: M001361570
• Device Catalogue Number: M001361570
• Device Lot Number: 0033804722
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2025
• Initial Report FDA Received Date: 05/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2024
• 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 Age: 49 YR
• Patient Sex: Female
• Patient Weight: 60 KG