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

Model Number	M001361620
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/19/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation results: device history record (dhr) review: it was confirmed this device met manufacturing specifications prior to distribution and there were no manufacturing deviations that could have contributed to the reported event.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause not established.
Event or Problem Description
It was reported that coil pack migration occurred requiring additional intervention.The target lesion was located in the mildly calcified subclavian vessel.A 12 mm x 30 cm interlock was selected for use.The coil pack was initially successfully implanted.The patient was brought to the cardiac intensive care unit (cicu), had an x-ray and it was noted that the coil migrated to the bronchial artery due to an anterograde flow likely caused by the stent graft.The patient returned the following day, one day post op and the coil pack was successfully removed via snare.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: ricardo amaro castro ; 4100 hamline ave n; arden hills, MN 55112 ; 9529306396
• MDR Report Key: 25549314
• Report Number: 2124215-2026-32635
• Device Sequence Number: 14865205
• Product Code: KRD
• UDI-Device Identifier: 08714729765059
• UDI-Public: (01)08714729765059(17)260801(10)32341790
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K132578
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/18/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 05/21/2026
• Initial Report FDA Received Date: 06/18/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown