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

Model Number	M001363670
Medical Device Problem Codes	Break (1069); Failure to Advance (2524); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E1: initial reporter address 1: (b)(6).E1: initial reporter phone: (b)(6).
Event or Problem Description
It was reported that coil protruding occurred requiring intervention.The target lesion was located in the internal iliac artery.A 18mm x 40cm interlock? 35 was selected for use.During the procedure, it was noted that coil could not continue to advance normally after multiple attempts, and repeated attempts still failed to advance.Upon withdraw, it was noted the coil tail remained (across the left internal iliac artery-left common iliac artery-right common iliac artery), and then the coil was retrieved using a catcher out of the patient's body.The procedure was completed with another of the same device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
(b)(6).Investigation results: device/media analysis: visual and microscopic inspection revealed that the main coil was bent and stretched at the primary coil section, moreover the arm coil detached.Device history record (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.Risk review: a risk review was completed and confirmed that the event of main coil unable to advance in catheter, coil protruding from target location, break, coil main bent/kinked, detached/separated and stretched were defined in the risk documentation and is documented accordingly in the prr.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: boston scientific concludes the most probable root cause as adverse event related to procedure.During the product analysis, it was observed that the main coil was returned.It was observed that the main coil was bent and stretched at the primary coil section, moreover the arm coil detached, since the pushing force of the user and this opposing force caused by friction are not parallel to each other, as it is related to excessive manipulation of the device and the technique used by the physician during the procedure, the main coil could be affected and consequently collapse forming the damage, this could possibly have affected the performance and integrity of the device.Moreover, a device history record (dhr) review was conducted and no deviations that could have contributed to the reported event were found.
Event or Problem Description
It was reported that coil protruding occurred requiring intervention.The target lesion was located in the internal iliac artery.A 18mm x 40cm interlock?-35 was selected for use.During the procedure, it was noted that coil could not continue to advance normally after multiple attempts, and repeated attempts still failed to advance.Upon withdraw, it was noted the coil tail remained (across the left internal iliac artery-left common iliac artery-right common iliac artery), and then the coil was retrieved using a catcher out of the patient's body.The procedure was completed with another of the same device.There were no patient complications as a result of this event.

• 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: 24125565
• Report Number: 2124215-2026-03723
• Device Sequence Number: 20330291
• Product Code: KRD
• UDI-Device Identifier: 08714729795414
• UDI-Public: (01)08714729795414(17)280318(10)36100659
• 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): 03/20/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M001363670
• Device Catalogue Number: M001363670
• Device Lot Number: 0036100659
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/24/2025
• Supplement Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 01/20/2026
• Supplement Report FDA Received Date: 03/20/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 50 KG