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); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 08jul2025.It was reported that the coil was unable to advance and unable to be withdrawn from the catheter.The target lesion was located in the abdominal aortic aneurysm.An 8mm x 40cm interlock -35 was selected for use.During the procedure, a 5f single-bend catheter was advanced into the internal iliac artery and into the controllable coil of the bsc 35 system.However, due to the y-valve connection being too stuck, the coil could not move forward.It was pushed repeated but failed, also the heparin water could not be flushed either.Upon withdrawing, the coil could not be withdrawn.Therefore, the catheter was withdrawn from the lumen together.The procedure was completed with another of the same device.There were no patient complications as a result of this event.However,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 detached main coil.
Additional Manufacturer Narrative
Device evaluated by mfr: only the main coil was returned for evaluation.Visual and microscope inspections were performed.It was observed that the main coil was bent and stretched and detached at the coil arm section, moreover the main coil lost the form.Dimensional inspection of the main coil revealed the components were within specification.No other issues were identified during 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: 22733625
• Report Number: 2124215-2025-50379
• Device Sequence Number: 8418686
• Product Code: KRD
• UDI-Device Identifier: 08714729793014
• UDI-Public: (01)08714729793014(17)260522(10)31673657
• 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): 08/06/2025

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: 05/22/2026
• Device Model Number: M001363590
• Device Catalogue Number: M001363590
• Device Lot Number: 0031673657
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2025
• Initial Report FDA Received Date: 08/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2023
• 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: 72 YR
• Patient Sex: Male
• Patient Weight: 63 KG