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

Model Number	M001361950
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported coil was broken inside the catheter.The target lesion was located in the a 20mm x 50cm interlock coil was selected for splenic aneurysm embolization.However, it was noted that the coil was broken inside the catheter.The procedure was completed with another of the same device.There were no patient complications as a result of this event, and the patient was stable post-procedure.
Event or Problem Description
It was reported coil was broken inside the catheter.The target lesion was located in the a 20mm x 50cm interlock coil was selected for splenic aneurysm embolization.However, it was noted that the coil was broken inside the catheter.The procedure was completed with another of the same device.There were no patient complications as a result of this event, and the patient was stable post-procedure.
Additional Manufacturer Narrative
Device technical analysis: upon receipt at our post market quality assurance laboratory, it was observed that the pusher wire was returned.It was observed that the pusher wire was bent, stretched and detached at the interlocking arm section.Dimensional inspection of the pusher wire revealed the components were within specification.No other issues were identified during the product analysis.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.Risk review: a risk review was completed and confirmed that the event of wire pusher broken, bent/kinked and stretched were defined in the risk documentation and is documented accordingly in the prr.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of adverse event related to procedure.

• 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: 23818519
• Report Number: 2124215-2025-91136
• Device Sequence Number: 13086329
• Product Code: KRD
• UDI-Device Identifier: 08714729845317
• UDI-Public: (01)08714729845317(17)271103(10)35406250
• 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): 04/09/2026

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: M001361950
• Device Catalogue Number: M001361950
• Device Lot Number: 0035406250
• 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: 11/20/2025
• Supplement Date Received by Manufacturer: 03/13/2026
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/03/2024
• 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: 77 YR
• Patient Sex: Male
• Patient Weight: 71 KG