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

Model Number	M001363600
Medical Device Problem Codes	Separation Failure (2547); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: healthcare facility name: (b)(6).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 of the coil was detached.Dimensional inspection was performed, and the main coil's max zap tip outer diameter (od) and primary coil max od passed the specification test.
Event or Problem Description
Reportable based on device analysis completed on 26may2025.It was reported that the coil failed to separate.The patient underwent hepatic arterial chemoembolization.The target location was tortuous with a malignant tumor in the liver.A 10mm x 20cm 2d interlock-35 was advanced for embolization.During the procedure, the coil entered the patient's body, but the coil could not be detached.The device was pulled out, and the procedure was completed with another of the same coil for embolization.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 of the coil was detached.

• 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: 22310044
• Report Number: 2124215-2025-39889
• Device Sequence Number: 12747079
• Product Code: KRD
• UDI-Device Identifier: 08714729793137
• UDI-Public: (01)08714729793137(17)260914(10)32432166
• 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): 06/23/2025

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: 09/14/2026
• Device Model Number: M001363600
• Device Catalogue Number: M001363600
• Device Lot Number: 0032432166
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2025
• Initial Report FDA Received Date: 06/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2023
• 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
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 58 KG