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

Model Number	M001361510
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	07/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Good faith effort attempts were made to try and retrieve additional details regarding the patient, initial reporter, and facility, but further information was unable to be obtained.If additional details become available, a supplemental report will be submitted.Device evaluated by mfr: only the pusher wire was returned to our post market quality assurance laboratory.Visual and microscopic inspections were performed, and it was possible to see that the pusher wire was kinked at the heat shrink tfe tubing section and the device was broken in half.Moreover, the part of the distal solder/coil arm was missing, and it was no possible to take measurements, due that the device lost the form.No other issues were identified during the product analysis.
Event or Problem Description
Reportable based on device analysis completed on 25sep2025.It was reported that the coil became stuck in the catheter.A 3mm x 12cm interlock coil was selected for arteriovenous malformation procedure (avm).However, during the procedure, it was noted that the coil became stuck in the catheter.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 pusher wire was broken in half and coil arm was missing.

• 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: 23356625
• Report Number: 2124215-2025-74484
• Device Sequence Number: 12976989
• Product Code: KRD
• UDI-Device Identifier: 08714729764946
• UDI-Public: (01)08714729764946(17)270212(10)33628956
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 10/22/2025

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: 0033628956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2025
• Initial Report FDA Received Date: 10/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2024
• 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: 54 YR
• Patient Sex: Male