MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTERLOCK?-35; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	M001363630
Medical Device Problem Codes	Entrapment of Device (1212); Stretched (1601); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that part of the coil stuck to the catheter tip and could not be withdrawn.The target lesion was located in the abdominal aorta and iliac artery.A 12mm x 40cm interlock - 35 was selected for use.During the procedure, the coil was advanced; however, after approximately 2 cm of deployment, the position was suboptimal, and the coil was retracted and re-advanced.During subsequent deployment, approximately one-third of the coil was deployed when it became stuck and could not be advanced or withdrawn.The coil and the single curve catheter were removed from the patient together as one unit.The same coil was reloaded and reattempted for delivery; however, the coil again became stuck after partial deployment and could not be advanced.The entire system was withdrawn, and inspection revealed the coil body was stretched and could not be deployed.The coil and catheter were removed together from the patient.The procedure was completed using two additional coils.There were no patient complications as a result of this event.
Event or Problem Description
It was reported that part of the coil stuck to the catheter tip and could not be withdrawn.The target lesion was located in the abdominal aorta and iliac artery.A 12mm x 40cm interlock - 35 was selected for use.During the procedure, the coil was advanced; however, after approximately 2 cm of deployment, the position was suboptimal, and the coil was retracted and re-advanced.During subsequent deployment, approximately one-third of the coil was deployed when it became stuck and could not be advanced or withdrawn.The coil and the single curve catheter were removed from the patient together as one unit.The same coil was reloaded and reattempted for delivery; however, the coil again became stuck after partial deployment and could not be advanced.The entire system was withdrawn, and inspection revealed the coil body was stretched and could not be deployed.The coil and catheter were removed together from the patient.The procedure was completed using two additional coils.There were no patient complications as a result of this event.It was further reported that no portion of the coil was protruding from the catheter tip upon removal.
Additional Manufacturer Narrative
E1: initial reporter facility name -(b)(6).E1: initial reporter phone number - (b)(6).Device history records (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.Labeling review: review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Investigation conclusion: based on a thorough review of the reported complaint, the most probable cause for this complaint was unintended use error caused or contributed to event.

• Brand Name: INTERLOCK?-35
• 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: 24674485
• Report Number: 2124215-2026-16037
• Device Sequence Number: 21386164
• Product Code: KRD
• UDI-Device Identifier: 08714729792970
• UDI-Public: (01)08714729792970(17)271022(10)35117788
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K133208
• 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): 04/14/2026

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: M001363630
• Device Catalogue Number: M001363630
• Device Lot Number: 0035117788
• 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: 02/26/2026
• Supplement Date Received by Manufacturer: 03/22/2026
• Initial Report FDA Received Date: 03/24/2026
• Supplement Report FDA Received Date: 04/14/2026
• Date Device Manufactured: 10/22/2024
• 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: 60 YR
• Patient Sex: Male
• Patient Weight: 65 KG