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

Model Number	M001361550
Medical Device Problem Codes	Stretched (1601); Failure to Advance (2524); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 27mar2026.It was reported that device unable to advance and stretched occurred.The target lesion was located in the arm.A 5mm x 15cm interlock was selected for use.During the procedure, it was noted that the coil could not be pushed out of the sheath.Upon removal, the coil was stretched.The procedure was completed with another of the same device.There were no patient complications as a result of this event.However, returned device analysis revealed a broken pusher wire.
Additional Manufacturer Narrative
E1: initial reporter address 1: (b)(6).E1: initial phone: (b)(6).Investigation results: device evaluated by mfr: the introducer sheath and the pusher wire were returned to our post market quality assurance laboratory.The returned unit was split into two pieces.Visual and microscopic inspection revealed that the pusher wire was bent and detached at the heat shrink tfe tubing section, moreover the interlocking arm was bent and stretched.The introducer sheath was also observed to be damaged.The outer diameters of the pusher wire were inspected and were within specification.Device history record: it was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of adverse event related to procedure.

• 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: ricardo amaro castro ; 4100 hamline ave n; arden hills, MN 55112 ; 9529306396
• MDR Report Key: 24939785
• Report Number: 2124215-2026-21461
• Device Sequence Number: 8926744
• Product Code: KRD
• UDI-Device Identifier: 08714729764984
• UDI-Public: (01)08714729764984(17)270817(10)34855460
• 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): 04/21/2026

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: M001361550
• Device Catalogue Number: M001361550
• Device Lot Number: 0034855460
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2026
• Initial Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/16/2024
• 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: 52 YR
• Patient Sex: Female
• Patient Weight: 63 KG