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

Model Number	M001363660
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Boston scientifc coil did not deploy.

• 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
• MDR Report Key: 25665449
• Report Number: 25665449
• Device Sequence Number: 10447755
• Product Code: KRD
• UDI-Device Identifier: 08714729797432
• UDI-Public: (01)08714729797432
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/15/2026
• Report Date (Section F): 05/15/2026

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: M001363660
• Device Catalogue Number: M001363660
• Device Lot Number: 34335284
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/30/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/30/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 05/15/2026