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

Model Number	M001363610
Medical Device Problem Codes	Premature Activation (1484); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 06feb2026.It was reported that premature deployment occurred.A 10mm x 40cm interlock?-35 was selected for use in a procedure.During the event, the interlock?-35 was damaged and separated inside of the delivery sheath, which caused premature deployment.Additional information has been requested through the good faith effort (gfe) process regarding patient condition and procedure details; however, no additional information has been received.However, device analysis revealed the coil arm was detached.
Additional Manufacturer Narrative
Device evaluation by manufacturer: the interlock-35 main coil, introducer sheath and the delivery wire were returned for analysis.Inspection did not identify failures or evidence that could be lost due to decontamination process.Visual and microscopic evaluation identified that the main coil was detached at the arm coil and stretched (losing form) at the primary coil section.

• 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: 24379743
• Report Number: 2124215-2026-09136
• Device Sequence Number: 10208653
• Product Code: KRD
• UDI-Device Identifier: 08714729793168
• UDI-Public: (01)08714729793168(17)280218(10)35877565
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/18/2026

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: M001363610
• Device Catalogue Number: M001363610
• Device Lot Number: 0035877565
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2026
• Initial Report FDA Received Date: 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/18/2025
• 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 Sex: Unknown