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

Model Number	M001363800
Medical Device Problem Codes	Failure to Advance (2524); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initials reporter facility name - (b)(6) hospital.E1: initial reporter phone number - (b)(6).Investigation results: device technical analysis: the main coil, the introducer sheath, and the delivery wire were returned for analysis.The visual and microscopic inspections revealed the main coil was bent and stretched at the primary coil section, and the arm coil was detached.The measurable coil dimensions were inspected and were within specification.Dhr (device history record) 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 events of main coil unable to advance in catheter, bent/kinked, stretched and detached/separated are known events defined in the products risk management documentation.These events hav been accounted for during product risk analysis to support acceptable risk benefit for the product.Conclusion: based on the complaint review, the most probable cause was adverse event related to procedure.Product analysis found the main coil bent and stretched with the arm coil detached, consistent with excessive manipulation and procedural technique causing opposing forces during use.A device history record (dhr) review identified no manufacturing deviations.Therefore, the event was attributed to procedural factors and the device had no influence on the event.
Event or Problem Description
Reportable based on the device analysis completed on 18feb2026 it was reported that the coil was unable to advance in the catheter.The target lesion was located in the iliac artery.A 10mm x 40cm interlock - 35 was selected for use.During the procedure, the coil was advanced into the catheter, it tired many times but it still could not be advanced into the catheter.The procedure was completed by replacing with another of the same coil.There were no patient complications as a result of this event.However, device analysis revealed a main coil detachment.

• 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: 24620073
• Report Number: 2124215-2026-14613
• Device Sequence Number: 18687387
• Product Code: KRD
• UDI-Device Identifier: 08714729795513
• UDI-Public: (01)08714729795513(17)270319(10)33659283
• 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
• Report Date (Section B): 03/17/2026

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: M001363800
• Device Catalogue Number: M001363800
• Device Lot Number: 0033659283
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2026
• Initial Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/19/2024
• 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: 88 YR
• Patient Sex: Male
• Patient Weight: 60 KG