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

Model Number	M001361950
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	06/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: the main coil, the introducer sheath and the pusher wire were returned for analysis.Visual and microscope inspections were performed.It was observed that the main coil was bent and stretched at the coil arm, zap tip and all primary coil section; moreover, the arm coil was also detached.Dimensional inspection of the main coil revealed the components were within specification.No other issues were identified with the device.
Event or Problem Description
Reportable based on device analysis completed on 30apr2025.It was reported that coil was unable to advance in the catheter.The target lesion was located in the left pulmonary artery.A non-bsc microcatheter and a 20mm x 50cm interlock was used for treatment.During the procedure, the coil was deployed using continuous saline flush.And was advanced through a non-bsc microcatheter.When the coil was advanced midway, it was noted that the coil became stuck in the catheter and could not be advanced further.The whole system was removed, and 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.

• 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: 22104381
• Report Number: 2124215-2025-33067
• Device Sequence Number: 18201001
• Product Code: KRD
• UDI-Device Identifier: 08714729845317
• UDI-Public: (01)08714729845317(17)260828(10)32523716
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/29/2025

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 Expiration Date: 08/28/2026
• Device Model Number: M001361950
• Device Catalogue Number: M001361950
• Device Lot Number: 0032523716
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2025
• Initial Report FDA Received Date: 05/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/28/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MICROCATHETER: PROGREAT
• Patient Age: 54 YR
• Patient Sex: Male