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

Model Number	M001363610
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Advance (2524); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 30dec2025.It was reported that the coil could not be advanced or withdrawn from the catheter.The target lesion was located in the common iliac artery.A 10mm x 40cm interlock.035 coil was selected for use in an endovascular graft exclusion of abdominal aorta to treat common iliac artery aneurysm combined with internal iliac artery aneurysm.During the procedure, it was noted that the coil could not be advanced from the catheter after partial deployment, nor could it be withdrawn.The coil along with the catheter were withdrawn from the patient.The procedure was completed with another of the same device.There were no patient complications as a result of this event and the patient status was stable post procedure.However, device analysis revealed a detached interlocking 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.Visual inspection identified that the main coil was bent and stretched at the primary coil section, moreover the arm coil was detached.The pusher wire was stretched at the distal section and interlocking arm was detached.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: 24188937
• Report Number: 2124215-2026-04624
• Device Sequence Number: 18541782
• Product Code: KRD
• UDI-Device Identifier: 08714729793168
• UDI-Public: (01)08714729793168(17)271126(10)35366285
• 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): 01/27/2026

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: M001363610
• Device Catalogue Number: M001363610
• Device Lot Number: 0035366285
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2025
• Initial Report FDA Received Date: 01/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/26/2024
• 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: 81 YR
• Patient Sex: Male
• Patient Weight: 59 KG