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

Model Number	M001361570
Medical Device Problem Codes	Stretched (1601); 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	05/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter facility name: (b)(6).Device eval by manufacturer: the device was returned for analysis.The components received included the main coil, the introducer sheath, and the pusher wire.Upon visual and microscopic inspection, the main coil was noted to be bent and stretched.Additionally, the main coil was found to be detached at the coil arm section.Dimensional inspection of the returned components was performed and confirmed to be within specification.
Event or Problem Description
Reportable based on the device analysis completed on 04aug2025.It was reported that the coil was stuck in the catheter.A 6mm x 20cm interlock device was selected for use in a splenic artery aneurysm embolization procedure.During the procedure, when attempting to place this interlock coil, the coil became stuck in the boston scientific catheter and could not be advanced.The device was then withdrawn, at which time the coil was observed to be stretched.Both the coil and the microcatheter were removed together from the patient's body, and the procedure was completed using with another of the same device.There were no patient complications as a result of this event, and the patient's condition was stable following the procedure.However, analysis of the returned device 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: 22923313
• Report Number: 2124215-2025-58766
• Device Sequence Number: 9144335
• Product Code: KRD
• UDI-Device Identifier: 08714729765004
• UDI-Public: (01)08714729765004(17)270817(10)34855465
• 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): 08/29/2025

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: M001361570
• Device Catalogue Number: M001361570
• Device Lot Number: 0034855465
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2025
• Initial Report FDA Received Date: 08/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/16/2024
• 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: 82 YR
• Patient Sex: Male
• Patient Weight: 55 KG