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

Model Number	M001363830
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	04/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 13jun2025.It was reported that the coil could not be pushed.The target lesion was located in the internal iliac artery.A 20mm x 40cm interlock-35 coil was advanced through 5f non-boston scientific single-curve catheter.However, the coil could not be pushed out from the catheter.Another 20x40 controllable coil was used and completed the procedure 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 arm coil was detached.
Additional Manufacturer Narrative
Device evaluation by manufacturer: visual and microscopic inspection observed that the main coil, the introducer sheath and the delivery wire were returned for analysis.The main coil was bent and stretched at the coil arm and primary coil section.Moreover the arm coil was detached.Dimensional inspection was performed, and the main coil's primary outer diameter (od) and coil arm 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: 22469941
• Report Number: 2124215-2025-40642
• Device Sequence Number: 18127771
• Product Code: KRD
• UDI-Device Identifier: 08714729795445
• UDI-Public: (01)08714729795445(17)271021(10)35106786
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 07/10/2025

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: M001363830
• Device Catalogue Number: M001363830
• Device Lot Number: 0035106786
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2025
• Initial Report FDA Received Date: 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2024
• 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: 59 YR
• Patient Sex: Male
• Patient Weight: 68 KG