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

Model Number	M001361960
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter address 1: (b)(6).Device evaluation by manufacturer: the device was returned for analysis.Visual and microscopic inspection observed that the main coil, the introducer sheath and the pusher wire were returned.The main coil was bent and stretched at the coil arm, primary coil and zap tip section.The pusher wire was kinked and detached at the heat shrink tfe tubing.The introducer sheath was kinked.Dimensional inspection was performed, and the main coil's coil arm outer diameter (od), zap tip od and primary coil od passed the specification test.Additionally, the pusher wire distal solder joint od, mid solder joint od, distal tfe od and proximal tfe also passed the specification test.
Event or Problem Description
Reportable based on device analysis completed on 16may2025.It was reported that the coil could not be deployed.A 22mm x 60cm 2d interlock coil was delivered through stc microcatheter for splenic aneurysm procedure.However, the coil could not be completely deployed.The physician tried to withdraw and deploy it again for many attempts, but still could not be deployed.The heparin saline was dripped continuously, and then the procedure was completed with a different coil.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 pusher wire was detached.

• Brand Name: INTERLOCK
• 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: 22196983
• Report Number: 2124215-2025-35709
• Device Sequence Number: 18576707
• Product Code: KRD
• UDI-Device Identifier: 08714729845324
• UDI-Public: (01)08714729845324(17)260926(10)32732476
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K132578
• 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): 06/12/2025

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: 09/26/2026
• Device Model Number: M001361960
• Device Catalogue Number: M001361960
• Device Lot Number: 0032732476
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2025
• Initial Report FDA Received Date: 06/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/27/2023
• 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: 40 YR
• Patient Sex: Female
• Patient Weight: 52 KG