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

Model Number	M001361530
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the coil was fractured.A 4mm x 15cm 2d interlock coil was selected for contrast medium arteriography procedure.However, the coil fractured during insertion.The procedure was completed with another of the same device.There were no patient complications as a result of this event, and the patient condition following procedure was stable.
Event or Problem Description
It was reported that the coil was fractured.A 4mm x 15cm 2d interlock coil was selected for contrast medium arteriography procedure.However, the coil fractured during insertion.The procedure was completed with another of the same device.There were no patient complications as a result of this event, and the patient condition following procedure was stable.
Additional Manufacturer Narrative
Device evaluation by manufacturer: visual inspection observed that the introducer sheath and the rhv were returned for analysis.There were no damages observed in the sections returned.The main coil was not returned, so the reported coil fracture could not be confirmed.

• 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: 21791151
• Report Number: 2124215-2025-20440
• Device Sequence Number: 20998700
• Product Code: KRD
• UDI-Device Identifier: 08714729764960
• UDI-Public: (01)08714729764960(17)270413(10)34016833
• 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,Followup
• Report Date (Section B): 06/26/2025

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: M001361530
• Device Catalogue Number: M001361530
• Device Lot Number: 0034016833
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2025
• Supplement Date Received by Manufacturer: 05/30/2025
• Initial Report FDA Received Date: 04/07/2025
• Supplement Report FDA Received Date: 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2024
• 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: 72 YR
• Patient Sex: Male
• Patient Weight: 75 KG