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

Model Number	M001363590
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter facility name: (b)(6) hospital.Device evaluated by mfr: the interlock was returned for analysis.It was observed that only the main coil was returned.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.Dimensional inspection of returned components revealed they were in specification.
Event or Problem Description
Reportable based on device analysis completed on 26jun2025.It was reported that the coil was stuck in the catheter.The patient had abdominal aortic aneurysm and left and right internal iliac artery aneurysms.A 2d 8mm x 40cm.035 interlock was used in embolization of the left and right internal iliac arteries.During the procedure, a guidewire was used to reach the left internal iliac artery from the right puncture opening.After the guidewire was placed a 5f non-boston scientific angiography catheter was used for superselection to reach the embolization position.When the coil was used, the coil could not be pushed out of the catheter.Several attempts were made; however, the coil still failed to be pushed out.Additionally, the coil could not be withdrawn and was removed together with the catheter.The procedure was completed with another of the same device.There were no patient complications as a result of this event.However, returned device analysis revealed a coil break.

• 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: 22591529
• Report Number: 2124215-2025-49756
• Device Sequence Number: 15716487
• Product Code: KRD
• UDI-Device Identifier: 08714729793014
• UDI-Public: (01)08714729793014(17)260614(10)31825866
• 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): 07/24/2025

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 Expiration Date: 06/14/2026
• Device Model Number: M001363590
• Device Catalogue Number: M001363590
• Device Lot Number: 0031825866
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2025
• Initial Report FDA Received Date: 07/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2023
• 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: 70 YR
• Patient Sex: Male
• Patient Weight: 67 KG