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

Model Number	M001363550
Medical Device Problem Codes	Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: it was observed that the main coil, the introducer sheath, and the delivery wire were returned.Visual and microscopic 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 of the coil was detached.Additionally, the coil memory was lost since it was deformed and bent.Dimensional inspection of the main coil revealed the components were within specification.
Event or Problem Description
Reportable based on device analysis completed on 27may2025.It was reported that the coil was drooping.The target lesion was located in the testis artery.A 6mm x 20cm, interlock.035 was selected for use.During the procedure, the coil was drooping.Due to unintentional detachment, it was hard to do embolization as planned with the device.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: 22310705
• Report Number: 2124215-2025-40372
• Device Sequence Number: 7997902
• Product Code: KRD
• UDI-Device Identifier: 08714729793021
• UDI-Public: (01)08714729793021(17)270319(10)33659058
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 06/23/2025

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: M001363550
• Device Catalogue Number: M001363550
• Device Lot Number: 0033659058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2025
• Initial Report FDA Received Date: 06/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/19/2024
• 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: 41 YR
• Patient Sex: Male