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

Model Number	M001363800
Medical Device Problem Codes	Premature Activation (1484); Failure to Advance (2524); Difficult to Advance (2920); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 20dec2024.It was reported that the coil could not be advance.The patient had abdominal aortic aneurysm and internal iliac artery aneurysm.During the procedure, a 15x40 interlock-35 coil was placed for embolization, and then this 10mm x 40cm interlock-35 coil was selected.When this coil was crossed, there was resistance occurred, and it could not be pushed out.After repeated attempts, this coil was withdrawn and found the head end of the coil was kink.The procedure was completed with another of the same device.No complications were reported.However, returned device analysis revealed detached coil arm.
Additional Manufacturer Narrative
E1 initial reporter city: (b)(6).Device evaluated by mfr.: the device was returned for analysis.Visual and microscopic inspection observed that the main coil, the introducer sheath and the delivery wire were returned.It was observed that the main coil was bent and stretched at the coil arm, zap tip and primary coil section.Moreover, the arm coil was detached.Functional inspection could not be performed due the main coil and the pusher wire are not interlocking.Dimensional inspection was performed, and the main coil's max zap tip outer diameter (od) and primary coil od passed the specification test.Based on the evidence, the reported allegations of mail coil unable to advance in the catheter, kink and difficult to advance in the catheter was confirmed, since the detached, bent and stretched coil was found during the product inspection that could have contributed to the reported issues.

• 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: 21164033
• Report Number: 2124215-2024-83452
• Device Sequence Number: 18526241
• Product Code: KRD
• UDI-Device Identifier: 08714729795513
• UDI-Public: 08714729795513
• 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): 01/15/2025

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: M001363800
• Device Catalogue Number: M001363800
• Device Lot Number: 0033469141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2024
• Initial Report FDA Received Date: 01/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2024
• 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: 74 YR
• Patient Sex: Male
• Patient Weight: 72 KG