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

Model Number	M001363820
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	12/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2026.It was reported that the main coil could not be pushed.The patient presented with bilateral iliac aneurysms, including involvement of the internal iliac artery.A 15mm x 40cm interlock 35 was selected for embolization.Access was obtained via the left puncture site, and a guidewire was advanced into the right internal iliac artery.Following guidewire placement, angiography was performed using a cordis 5f angiography catheter positioned at the target embolization site.The 15mm x 40cm interlock-35 coil was advanced; however, the coil could not be pushed out of the catheter for deployment.Multiple attempts were made by the physician to deploy the coil, but these attempts were unsuccessful.The device was removed and replaced with another 15mm x 40cm interlock-35 coil of the same specification, which was successfully used to complete the embolization.The patient remained stable following the procedure as a result of this event however, device analysis revealed that the arm coil was detached.
Additional Manufacturer Narrative
E1: initial reporter phone: (b)(6).Investigation results: device/media analysis: upon receipt at our post market quality assurance laboratory, this interlock.035 device was examined.Visual and microscopic inspection showed the main coil was deformed and stretched at the primary coil section, moreover the arm coil and the zap tip were detached.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.Investigation conclusion: based on a thorough review of the reported event of main coil unable to advance in catheter, boston scientific has assigned an investigation conclusion code of unintended use error caused or contributed to event.Boston scientific has assigned an investigation conclusion code of adverse event related to procedure to the damages found during analysis.

• 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: 25205160
• Report Number: 2124215-2026-26679
• Device Sequence Number: 12980000
• Product Code: KRD
• UDI-Device Identifier: 08714729795438
• UDI-Public: (01)08714729795438(17)280325(10)36156381
• 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,Followup
• Report Date (Section B): 07/09/2026

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: M001363820
• Device Catalogue Number: M001363820
• Device Lot Number: 0036156381
• 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
• Supplement Date Received by Manufacturer: 06/14/2026
• Initial Report FDA Received Date: 05/18/2026
• Supplement Report FDA Received Date: 07/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/26/2025
• 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: ANGIOGRAPHY CATHETER: CORDIS 5F.
• Patient Age: 86 YR
• Patient Sex: Male
• Patient Weight: 63 KG