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

Model Number	M001361620
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - initial reporter phone: (b)(6).
Event or Problem Description
It was reported that coil migration occurred.The patient was admitted to hospital due to the discovery of a left foot mass.After completing necessary examinations and the patient was under moderate sedation, a 12mm x 30cm pe f-idc was selected for left lower extremity arteriography with coil embolization procedure to treat a vascular aneurysm cavity.During the procedure, a 2.7f non-boston scientific microcatheter was used to deploy the coil.As a result, the interlock arm of the coil was unlocked, and the coil was dislodged within the microcatheter.The coil's own guidewire was withdrawn, leaving the coil still within the catheter.The coil was then flushed out of catheter with heparinized saline, reinserted into the microcatheter, and the coil was pushed into the patient using a guide wire and ultimately deployed inside the body.The physician completed the procedure using this device.There were no patient complications as a result of this event.

• 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: 23072643
• Report Number: 2124215-2025-61386
• Device Sequence Number: 20030121
• Product Code: KRD
• UDI-Device Identifier: 08714729765059
• UDI-Public: (01)08714729765059(17)261117(10)33082633
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K132578
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 09/17/2025

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: M001361620
• Device Catalogue Number: M001361620
• Device Lot Number: 0033082633
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2025
• Initial Report FDA Received Date: 09/17/2025
• Date Device Manufactured: 12/18/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MICROCATHETER: 2.7F HENGRUI.
• Patient Age: 42 YR
• Patient Sex: Male