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

Model Number	M001363670
Medical Device Problem Codes	Premature Activation (1484); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E.1.Initial reporter address 1: (b)(6).Device evaluated by manufacturer: the device was returned for analysis.Visual and microscopic inspection observed that the main coil was bent and stretched at the primary coil and zap tip section, moreover the arm coil was detached.Dimensional inspection on the zap tip outer diameter and primary coil outer diameter were within specification.
Event or Problem Description
Reportable based on device analysis completed on 21aug2025.A 18mm x 40cm intelock-35 was selected for use.During the procedure, a continuous flushing was done before introduction of coil.Subsequently, the coil got detached inside the 5f delivery catheter.The procedure was completed using an alternative device.No patient complications were reported.However, device analysis revealed that the main 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 MN
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 23085688
• Report Number: 2124215-2025-64027
• Device Sequence Number: 16079349
• Product Code: KRD
• UDI-Device Identifier: 08714729795414
• UDI-Public: (01)08714729795414(17)250214(10)28872937
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/18/2025

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: 02/14/2025
• Device Model Number: M001363670
• Device Catalogue Number: M001363670
• Device Lot Number: 0028872937
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2025
• Initial Report FDA Received Date: 09/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2022
• 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: 67 YR
• Patient Sex: Female
• Patient Weight: 65 KG
• Patient Race: Asian