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

Model Number	M001363650
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	03/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 19may2025.It was reported that the coil could not be pushed out.The target lesion was located in the abdomen.A 15mm x 40cm interlock-35 coil was selected for splenic artery aneurysm procedure.However, the coil could not be pushed out of the sheath during the procedure.The procedure was completed with another of the same device.There was no patient complications noted as a result of this event, and the patient condition following procedure was stable.However, returned device analysis revealed the main coil was detached.
Additional Manufacturer Narrative
Device evaluation by manufacturer: the device was returned for analysis.Visual and microscopic inspection observed that the main coil was returned with a non-boston scientific catheter.The main coil was stuck in the catheter, when removing the coil, it was observed that it was bent and stretched at the primary coil and coil arm section, moreover the arm coil was detached.Dimensional inspection was performed, and the main coil's max zap tip outer diameter (od) and primary coil od passed the specification test.

• 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: 22230643
• Report Number: 2124215-2025-35713
• Device Sequence Number: 9042400
• Product Code: KRD
• UDI-Device Identifier: 08714729793144
• UDI-Public: (01)08714729793144(17)270614(10)34247888
• 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): 06/17/2025

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: M001363650
• Device Catalogue Number: M001363650
• Device Lot Number: 0034247888
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2025
• Initial Report FDA Received Date: 06/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/14/2024
• 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: 58 YR
• Patient Sex: Female
• Patient Weight: 60 KG