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

Model Number	M001361620
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212); Difficult to Insert (1316); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - initial reporter facility name: (b)(6) medical center.
Event or Problem Description
It was reported that coil damage occurred.The target lesion was located the moderately tortuous and moderately calcified right internal iliac artery.A 12mm x 30cm interlock coil was selected for embolization.During the procedure, the device immediately became stiff when being inserted from the introducer into the microcatheter.Upon removal, it was noted that the tip of the coil was slightly protruding, and the coil itself was broken and frayed.The procedure was completed with another of the same device.No patient complications were reported.
Event or Problem Description
It was reported that coil damage occurred.The target lesion was located the moderately tortuous and moderately calcified right internal iliac artery.A 12mm x 30cm interlock coil was selected for embolization.During the procedure, the device immediately became stiff when being inserted from the introducer into the microcatheter.Upon removal, it was noted that the tip of the coil was slightly protruding, and the coil itself was broken and frayed.The procedure was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
E1 - initial reporter facility name: (b)(6).Correction report is being filed to update h6 (device codes).

• 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: 21399938
• Report Number: 2124215-2025-08459
• Device Sequence Number: 12820805
• Product Code: KRD
• UDI-Device Identifier: 08714729765059
• UDI-Public: 08714729765059
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2025

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 Expiration Date: 08/01/2026
• Device Model Number: M001361620
• Device Catalogue Number: M001361620
• Device Lot Number: 0032341790
• 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: 01/21/2025
• Supplement Date Received by Manufacturer: 02/28/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 03/25/2025
• Date Device Manufactured: 09/01/2023
• 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: INTRODUCER SHEATH USED - 5F 11CM.; INTRODUCER SHEATH USED - 5F 11CM.; MICRO CATHETER - BREAKTHROUGH 2 MARKER.; MICRO CATHETER - BREAKTHROUGH 2 MARKER.
• Patient Sex: Unknown