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

Model Number	M001361950
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that coil failed to deploy requiring intervention.The target lesion was located vessel in the digestive tract.A 2d 20mm x 50cm pe f-idc was selected for use.During the procedure, it was noted that the coil could not be deployed.The device was removed with the assistance of a snare, and no device fragments were found in the blood vessel.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
E1: initial reporter phone: (b)(6).
Additional Manufacturer Narrative
E1: initial reporter phone: (b)(6).B5: describe event or problem: updated.Investigation details: device history record (dhr) review: it was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Risk review: a risk review was completed and confirmed that the event of failure to separate was defined in the risk documentation.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 unable to exclude device problem.
Event or Problem Description
It was reported that coil failed to deploy requiring intervention.The target lesion was located vessel in the digestive tract.A 2d 20mm x 50cm pe f-idc was selected for use.During the procedure, it was noted that the coil could not be deployed.The device was removed with the assistance of a snare, and no device fragments were found in the blood vessel.There were no patient complications as a result of this event.It was further confirmed that there were no observations of premature deployment, coil break or malposition of the coil.

• 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: 24442788
• Report Number: 2124215-2026-10369
• Device Sequence Number: 13355457
• Product Code: KRD
• UDI-Device Identifier: 08714729845317
• UDI-Public: (01)08714729845317(17)271231(10)35745354
• 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): 03/25/2026

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 Model Number: M001361950
• Device Catalogue Number: M001361950
• Device Lot Number: 0035745354
• 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: 01/28/2026
• Supplement Date Received by Manufacturer: 02/28/2026
• Initial Report FDA Received Date: 02/25/2026
• Supplement Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/30/2025
• 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 Age: 62 YR
• Patient Sex: Male
• Patient Weight: 66 KG