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

Model Number	M001363650
Medical Device Problem Codes	Premature Activation (1484); Difficult to Remove (1528); 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	03/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - initial reporter address 1: (b)(6).E1 - initial reporter phone: (b)(6).Investigation results: device evaluated by mfr: the interlock.035 device was returned to our post market quality assurance laboratory.A visual and microscopic inspection was performed and identified that the main coil was bent and stretched at the primary coil section, moreover the arm coil was detached.Dimensional inspection of the main coil revealed the components were within specifications.This concludes the product analysis.Device history record: 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: review of the instructions for use (ifu) confirmed that the ifu states 'the interlock - 35 fibered idc occlusion system is designed to be delivered under fluoroscopy through a 5f (1.70 mm) od (0.035 in [0.89 mm] or 0.038 in [0.97 mm] inner lumen) imager? ii selective diagnostic catheter without side flushing holes'.The customer states that the catheter used was a non-boston scientific catheter.Boston scientific corporation provides no warranty for use of third party catheters with its products.The use of other diagnostic catheters may result in an inability to deliver, deploy, or recapture the device.Investigation conclusion: based on a thorough review of the reported events of main coil unable to advance in catheter and main coil unable to withdraw from catheter, boston scientific has assigned an investigation conclusion code of unintended use error caused or contributed to event.This code was selected because the customer used a non-boston scientific catheter that was not recommended for use instead of the recommended imager ii.Additionally, device analysis revealed that the main coil was bent and stretched at the primary coil section, moreover the arm coil was detached.Boston scientific has assigned an investigation conclusion code of adverse event related to procedure to the damages found during analysis.Finally, boston scientific has assigned an investigation conclusion code of cause not established regarding the event of main coil premature deployment inside patient as the coil could not be functionally evaluated.
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2026.It was reported that the coil could not be advanced and withdrawn from the catheter.A 15mm x 40cm interlock.035 coil was selected for use.During the procedure, it was noted that the coil was stuck in the catheter and could not be withdrawn.The procedure was completed with another of the same device.There were no patient complications as a result of this event.However, device analysis revealed that the main coil was bent and stretched at the primary coil section, moreover 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: ricardo amaro castro ; 4100 hamline ave n; arden hills, MN 55112 ; 9529306396
• MDR Report Key: 25222640
• Report Number: 2124215-2026-26997
• Device Sequence Number: 9973207
• Product Code: KRD
• UDI-Device Identifier: 08714729793144
• UDI-Public: (01)08714729793144(17)280421(10)36347082
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 05/19/2026

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: M001363650
• Device Catalogue Number: M001363650
• Device Lot Number: 0036347082
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2025
• 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
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 62 KG