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

Model Number	M001363800
Medical Device Problem Codes	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	03/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for analysis.Upon inspection, it was noted that the main coil, introducer sheath, and delivery wire were included in the return.To facilitate removal of the coil, it was necessary to make a cut in the introducer sheath.Observations revealed that the main coil was bent and stretched at the coil arm, zap tip, and primary coil section.Additionally, the zap tip was found to be detached.The main coil exhibited detachment, bending, and stretching.The measurable dimensions of the coil were inspected against the following drawings: assy,.035 interlock 2d coil, primary coil winding specification, and coil arm.
Event or Problem Description
Reportable based on the device analysis completed on (b)(6) 2025.It was reported that the coil could not be sent out in the delivery sheath.The stenosed target lesion was located in the lower extremity iliac artery.The patient underwent embolization of a left sagittal aneurysm with a dissecting component.Using the extension tube, a 35 controllable coil was deployed into the hemangioma of the affected area through a percutaneous puncture procedure.During deployment, the coil failed to deploy from the delivery sheath and could only be withdrawn.It was unable to advance forward through the catheter.As a result, a new 35 controllable coil was substituted.Additionally, one unit of the same model (m001363800) was replaced as backup.The procedure was completed using with another of the same device.There were no patient complications as a result of this event.However, returned device analysis revealed main coil detached.

• 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: 22472937
• Report Number: 2124215-2025-43661
• Device Sequence Number: 4172382
• Product Code: KRD
• UDI-Device Identifier: 08714729795513
• UDI-Public: (01)08714729795513(17)270816(10)34650135
• 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): 07/10/2025

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: M001363800
• Device Catalogue Number: M001363800
• Device Lot Number: 0034650135
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2025
• 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: 08/16/2024
• 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: 66 YR
• Patient Sex: Male
• Patient Weight: 81 KG