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

Model Number	M001363630
Medical Device Problem Codes	Premature Activation (1484); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - initial reporter facility name: (b)(6).Device evaluated by mfr: the main coil, the introducer sheath and the delivery wire were returned.Visual and microscope inspections were performed.It was observed that the main coil was bent and stretched at the coil arm and primary coil section, moreover the arm coil was detached.Dimensional inspection of the main coil revealed the components were within specification.No other issues were identified with the device.
Event or Problem Description
Reportable based on device analysis completed on 30apr2025.It was reported that the coil premature deployment occurred.The target lesion was located in the abdominal aorta.A 12mm x 40cm interlock-35 was selected for use.During advancement, it was noted that the coil was deployed prematurely and did not reach the tumor.The procedure was completed with another of same device.There were no patient complications as a result of this event.However, device analysis revealed that the 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: 22100064
• Report Number: 2124215-2025-33844
• Device Sequence Number: 12873686
• Product Code: KRD
• UDI-Device Identifier: 08714729792970
• UDI-Public: 08714729792970
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: 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: M001363630
• Device Catalogue Number: M001363630
• Device Lot Number: 0034650130
• 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: 08/16/2024
• 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: 66 YR
• Patient Sex: Male
• Patient Weight: 80 KG