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

Model Number	M001363730
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	01/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter address 1: / e1: initial reporter phone: (b)(6).Device evaluated by mfr: the interlock.035 device was returned for analysis.Visual inspection revealed the main coil was bent and stretched at the primary coil section, also the arm coil was detached.Microscopic inspection revealed the main coil was detached, bent and stretched.Dimensional inspection of the main coil 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.Labeling review review of the instructions for use (ifu) confirmed that the content was sufficient and did not contribute to the reported event; therefore, no updates are required to the document at this time.Risk review: a risk review performed for the interlock.035 device confirmed that the event of main coil detached/separated is known event defined in the products risk management 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 unintended use error caused or contributed to event instructions.
Event or Problem Description
Reportable based on device analysis completed on 09mar2026.It was reported that the main coil could not be pushed.A transcatheter renal artery embolization procedure was performed.Flushing was conducted via intermittent hand injection prior to coil introduction.After a cordis 5f c2 angiography catheter was in place, two interlock coils, 10 mm x 40 cm and 8 mm x 40 cm were used for embolization, and their deployment was smooth.When a 6 mm x 20 cm interlock coil was selected, the physician reported that it could not be pushed.The procedure was completed with another of same device.There were no patient complications as a result of this event, and the patient remained stable post-procedure.However, device analysis revealed that the arm coil was detached.

• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 24766894
• Report Number: 2124215-2026-18167
• Device Sequence Number: 18453503
• Product Code: KRD
• UDI-Device Identifier: 08714729793090
• UDI-Public: (01)08714729793090(17)270916(10)34855503
• 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): 04/02/2026

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: M001363730
• Device Catalogue Number: M001363730
• Device Lot Number: 0034855503
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/16/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ANGIOGRAPHY CATHETER: CORDIS5F C2
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 62 KG