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

Model Number	M001363800
Medical Device Problem Codes	Stretched (1601); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 26may2025.It was reported that the coil was stretched.A 10mm x 40cm interlock-35 coil was advanced for embolization of the hepatic artery.However, the coil stretched when it entered the microcatheter.The procedure was completed with another of the same device.There were no patient complications 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, the rhv, the introducer sheath and the delivery wire were returned.The main coil was bent and stretched at the primary coil section.Moreover, the arm coil was detached.The delivery wire was stretched and the introducer sheath was also detached.Dimensional inspection was performed, and the main coil's zap tip outer diameter (od) and primary coil od passed the specification test.The dimensional inspection of the delivery wire's max wield od, max wire arm od and max wire od also 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: 22309676
• Report Number: 2124215-2025-38459
• Device Sequence Number: 7937430
• Product Code: KRD
• UDI-Device Identifier: 08714729795513
• UDI-Public: (01)08714729795513(17)270628(10)34335293
• 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 Model Number: M001363800
• Device Catalogue Number: M001363800
• Device Lot Number: 0034335293
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2025
• 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: 06/28/2024
• 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: 63 YR
• Patient Sex: Male
• Patient Weight: 78 KG