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

Model Number	M001363830
Medical Device Problem Codes	Premature Activation (1484); Difficult to Advance (2920); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - initial reporter phone: (b)(6).Device analysis findings: the device was returned for analysis.Visual and microscopic inspection were performed, and it was observed that the main coil was bent and stretched at the primary coil section; moreover, the arm of the coil was detached.Dimensional inspection of the main coil revealed the components were within specifications.Device history record: it was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Labeling review: review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of unintended use error caused or contributed to event for the reported advancement difficulty.With regard to the reported premature deployment, boston scientific has concluded cause not established.Relating to the bent and stretched main coil with a detached coil arm that was discovered during device analysis, boston scientific has concluded adverse event related to procedure.
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2026.It was reported that the coil difficult to advance and premature deployment occurred.The target lesion was located in the internal iliac aneurysm.A 20mm x 40cm interlock.035 coil was selected for embolization.However, resistance was encountered during the delivery process of the coil.After repeated attempts, the interlocking arm dislodged.The procedure was completed with another of the same device.There were no patient complications as a result of this event, and the patient was stable post-procedure.However, device analysis revealed a detached coil arm.

• 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: ricardo amaro castro ; 4100 hamline ave n; arden hills, MN 55112 ; 9529306396
• MDR Report Key: 25392670
• Report Number: 2124215-2026-29878
• Device Sequence Number: 21507826
• Product Code: KRD
• UDI-Device Identifier: 08714729795445
• UDI-Public: (01)08714729795445(17)270608(10)34198249
• 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): 06/04/2026

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: M001363830
• Device Catalogue Number: M001363830
• Device Lot Number: 0034198249
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2026
• Initial Report FDA Received Date: 06/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/08/2024
• 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: 59 YR
• Patient Sex: Female
• Patient Weight: 68 KG