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

Model Number	M001363650
Medical Device Problem Codes	Nonstandard Device (1420); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 21jan2026.It was reported that the coil could not be advanced from the catheter.A 15mm x 40cm interlock.035 coil was selected for use in the common iliac artery aneurysm.During the procedure, it was noted that the coil could not be advanced from the catheter.The procedure was completed with another of the same device.There were no patient complications as a result of this event.However, device analysis revealed a detached coil arm.
Additional Manufacturer Narrative
E1 - initial reporter phone: (b)(6).Device evaluated by mfr: the interlock.035 device was returned to our post market quality assurance laboratory.A photo was provided from the healthcare facility that shows the introducer sheath and the coil inside.However, it cannot be determined if the main coil was damaged based on the media provided.Visual and microscopic inspection identified that the main coil had the coil arm detached, and it was stretched along the primary coil.Dimensional inspection of the main coil revealed the components were within specifications.This concludes the product analysis.

• 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: 24350950
• Report Number: 2124215-2026-08684
• Device Sequence Number: 11999955
• Product Code: KRD
• UDI-Device Identifier: 08714729793144
• UDI-Public: (01)08714729793144(17)270731(10)34545127
• 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): 02/16/2026

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: M001363650
• Device Catalogue Number: M001363650
• Device Lot Number: 0034545127
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2026
• Initial Report FDA Received Date: 02/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2024
• 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: 74 YR
• Patient Sex: Male
• Patient Weight: 68 KG