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

Model Number	M001363610
Medical Device Problem Codes	Entrapment of Device (1212); Device-Device Incompatibility (2919); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that coil stuck to catheter tip.The target lesion was located in the internal iliac artery.A 10mm x 40cm interlock.35 coil was selected for internal iliac embolization using an ipsilateral approach.During the procedure, the contrast catheter bounced back due to kickback, causing a hole in the contrast catheter and causing the coil side interlocking arm to get caught in the hole.Then, the sheath and the system were removed.The coil and the catheter were able to remove without any problem and there were no remains inside the patient.The procedure was completed with another of same device.There were no patient complications as a result of this event.

• 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: 22469428
• Report Number: 2124215-2025-44030
• Device Sequence Number: 8093883
• Product Code: KRD
• UDI-Device Identifier: 08714729793168
• UDI-Public: (01)08714729793168(17)270829(10)34741413
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/10/2025

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: M001363610
• Device Catalogue Number: M001363610
• Device Lot Number: 0034741413
• 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: 06/12/2025
• Initial Report FDA Received Date: 07/10/2025
• Date Device Manufactured: 08/29/2024
• 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: MICRO CATHETER: TECHNOWOOD CATHETER 4FR
• Patient Sex: Unknown