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

Model Number	M001361510
Medical Device Problem Codes	Difficult to Remove (1528); Stretched (1601); Failure to Advance (2524); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: the main coil was returned to our post market quality assurance laboratory.Visual inspection was performed, and it was observed that main coil was bent, stretched and detached at the coil arm section.Dimensional inspection of the main coil revealed the components were within specifications.No other issues were identified during the product analysis.
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2025.It was reported that the coil could not be advanced and withdrawn.A 3mm x 12cm interlock? 2d coil was selected for embolization of internal iliac artery branch.During the procedure, the coil was advanced through a 2.1f direxion microcatheter.However, it was noted that it could not continue to push and could not be withdrawn.As a result, the coil was withdrawn together with the catheter.Upon inspection, it was noted that the coil wire was stretched and kinked.The procedure was completed with another of the same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 the main coil was detached at the coil arm section.

• Brand Name: INTERLOCK?
• 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: 22469421
• Report Number: 2124215-2025-44295
• Device Sequence Number: 17202243
• Product Code: KRD
• UDI-Device Identifier: 08714729764946
• UDI-Public: (01)08714729764946(17)270416(10)34045090
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K132578
• 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): 07/10/2025

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 Model Number: M001361510
• Device Catalogue Number: M001361510
• Device Lot Number: 0034045090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2025
• Initial Report FDA Received Date: 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2024
• 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: 72 YR
• Patient Sex: Female
• Patient Weight: 86 KG