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

Model Number	M001361620
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2025
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 microscopic inspections revealed that the main coil was bent and stretched at the coil arm and primary coil section.Moreover, the arm of the coil was detached.Dimensional inspection of the main coil revealed the components were within specifications.
Event or Problem Description
Reportable based on device analysis completed on 03mar2025.It was reported that the coil was unable to advance.A 12mm x 30cm interlock was selected for use in the embolization of an intra-abdominal aneurysm in the superior mesenteric artery.During the procedure, heparin saline was dripped continuously, but it was noted that the coil could not be advanced further when advanced to the tail end of the renegade microcatheter.After several times of withdrawing and advancing the device, the problem still occurred.The procedure was completed with another of the same device.There were no patient complications as a result of this event.However, returned device analysis revealed that the arm of the coil was detached.

• 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: 21719610
• Report Number: 2124215-2025-18217
• Device Sequence Number: 17075886
• Product Code: KRD
• UDI-Device Identifier: 08714729765059
• UDI-Public: (01)08714729765059(17)270401(10)33944000
• 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): 03/28/2025

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: M001361620
• Device Catalogue Number: M001361620
• Device Lot Number: 0033944000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2025
• Initial Report FDA Received Date: 03/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: RENEGADE MICROCATHETER.
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 60 KG