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

Model Number	M001363610
Medical Device Problem Codes	Difficult to Remove (1528); Difficult to Advance (2920); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on the device analysis completed on (b)(6) 2026 it was reported that coil difficulty advancement occurred.The target lesion was located in the internal iliac vein.A 10mm x 40cm interlock - 35 was selected for use.During advancement of the second coil, resistance was encountered, and the coil could not be advanced or withdrawn independently.As a result, the coil and contrast catheter were withdrawn together.The coil was subsequently removed outside the patient.The angiography catheter was then replaced, and another coil of the same type was used.A total of two 0.035 system coils were utilized, and the procedure was successfully completed.The patients condition following the procedure was reported as stable.No complications were reported as a result of this event.However, returned device analysis revealed arm coil detached.
Additional Manufacturer Narrative
E1: initial reporter facility name - (b)(6).E1: initial reporter facility number - (b)(6).Device evaluation by manufacturer: the device was returned for evaluation.Examination confirmed that the main coil, introducer sheath, and delivery wire were received.Visual inspection identified deformation of the main coil, including bending and elongation within the primary coil section, and the arm coil was noted to be detached.Dimensional measurements, where obtainable, were evaluated against the applicable device design specifications.Device history records (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.Labeling review: the platinum coil incorporates synthetic fibers to enhance thrombogenicity.The interlock-35 fibered idc occlusion system is intended for delivery under fluoroscopic guidance through a compatible 5f (1.70 mm od) diagnostic catheter with an inner lumen of 0.035 in (0.89 mm) or 0.038 in (0.97 mm), such as the imager ii selective diagnostic catheter, and without side flushing holes.According to the customer, a cordis catheter was used during the procedure.Boston scientific does not validate or warrant the performance of its devices when used with third-party catheters.The use of non-specified or non-compatible diagnostic catheters may impact device performance, including the ability to deliver, deploy, or recapture the device.Risk review: a risk review performed for the interlock.035 device confirmed that the reported event is a known event defined in the product's risk management documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefits for the product.Investigation conclusion: based on a thorough review of the reported complaint, the most probable root cause is unintended use error caused or contributed to event instructions.

• 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: 24802225
• Report Number: 2124215-2026-18794
• Device Sequence Number: 15963101
• Product Code: KRD
• UDI-Device Identifier: 08714729793168
• UDI-Public: (01)08714729793168(17)270809(10)34605058
• 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): 04/07/2026

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: M001363610
• Device Catalogue Number: M001363610
• Device Lot Number: 0034605058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2026
• Initial Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2024
• 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: 65 YR
• Patient Sex: Male
• Patient Weight: 65 KG