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

Model Number	M001363590
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	11/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on the device analysis completed on (b)(6) 2026.It was reported that unable to advance coil occurred.The 100% stenosed target lesion was located in the mildly tortuous and mildly calcified internal iliac artery.An 8 mm x 40 cm interlock -35 was selected for use.During the procedure, the coil was stuck in the middle part of the catheter.The procedure was completed using with another of the same device.There were no patient complications as a result of this event.However, returned device analysis revealed a detached main coil.
Additional Manufacturer Narrative
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.Device evaluation by manufacturer: the device was returned for analysis.The returned components included the main coil, introducer sheath, and delivery wire.Examination showed that the main coil was detached at the arm coil, stretched at the primary coil section, and exhibited deformation.The measurable coil dimensions of the zap tip od and primary coil od were inspected against the applicable specifications and drawings, and met specification.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.The instructions for use (ifu) state that the platinum coil contains synthetic fibers for greater thrombogenicity.The interlock 35 fibered idc occlusion system is designed to be delivered under fluoroscopy through a 5f (1.70 mm) od (0.035 in or 0.038 in inner lumen) imager ii selective diagnostic catheter without side flushing holes.Investigation conclusion: boston scientific concludes the most probable root cause as failure to follow instructions.It was reported that the coil was stuck in the middle part of the catheter.Device analysis revealed the main coil was detached at the arm coil, stretched at the primary coil section, and exhibited deformation.The customer reported that the catheter used was tempo 4f.The use of other diagnostic catheters may result in an inability to deliver, deploy, or recapture the device.Regarding to the issues detached, deformed and stretched, found in the main coil during the product analysis, is the result of not following the instructions cited in the ifu.Risk review: a risk review performed for the interlock-35 device confirmed that the event of main coil unable to advance in catheter, coil in catheter fitting issue, stretched, coil main deformed and detached/separated are known events defined in the products risk management documentation.This event has been accounted for during product risk analysis to support acceptable risk benefit for the product.

• 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: 24530947
• Report Number: 2124215-2026-12506
• Device Sequence Number: 10371677
• Product Code: KRD
• UDI-Device Identifier: 08714729793014
• UDI-Public: (01)08714729793014(17)280318(10)36100641
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 03/06/2026

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: M001363590
• Device Catalogue Number: M001363590
• Device Lot Number: 0036100641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2026
• Initial Report FDA Received Date: 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/19/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE CATHETER (TEMPO 4F)
• Patient Sex: Unknown