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

Model Number	M001361930
Medical Device Problem Codes	Separation Failure (2547); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: the main coil, the introducer sheath and the pusher wire were returned to our post market quality assurance laboratory.Visual and microscopic inspections were performed, and it was observed that the main coil was tangled, and it was bent, stretched and detached at the coil arm section.Additionally, the pusher wire was bent at the distal tip.The pouch was returned, and it was observed that the pouch information matches with the complaint information.Dimensional inspection of the main coil and pusher wire revealed the components were within specifications.No other issues were identified during the product analysis.
Event or Problem Description
Reportable based on device analysis completed on 26sep2025.It was reported that the coil became entangled and could not be deployed.The patient presented with variceal in splenic underwent embolization with a 14mm x 50cm interlock coil.However, during the procedure, it was noted that the coil became entangled with the lock and did not detach from the lock after coming out of the micro catheter.The device was retrieved after 2nd attempts to avoid the incorrect placement of the coil.The procedure was completed with another of the same device.There were no patient complications as a result of this event.However, device analysis revealed the main coil was detached at the coil arm section.

• 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: 23371201
• Report Number: 2124215-2025-75182
• Device Sequence Number: 10122159
• Product Code: KRD
• UDI-Device Identifier: 08714729845294
• UDI-Public: 08714729845294
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/23/2025

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: M001361930
• Device Catalogue Number: M001361930
• Device Lot Number: 0033756769
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2025
• Initial Report FDA Received Date: 10/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DELIVERY CATHETER - PREGREAT .021 ID.
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 68 KG