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	12/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 18feb2026.It was reported that the coil could not be advanced from the catheter.A 15mm x 40cm interlock.035 coil was selected for use in the abdominal aortic aneurysm.During the procedure, upon advancing the spring coil into the middle of the catheter, the spring coil could not be pushed out.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 detached.
Additional Manufacturer Narrative
E1 - (b)(6).Investigation results: device evaluated by mfr: the interlock.035 device was returned to our post market quality assurance laboratory.Visual and microscopic examination identified that the main coil was bent and stretched at the primary coil section, also the zap tip was detached.Dimensional inspection of the main coil revealed the components were within specifications.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 content was sufficient and did not contribute to the reported event; therefore, no updates are required to the document at this time.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: boston scientific concludes the most probable root cause as unintended use error caused or contributed to event instructions.It was reported that the coil could not be advanced from the cordis 5 f angiography catheter.Device analysis revealed the main coil was bent and stretched at the primary coil section, also the zap tip was detached.The instructions for use (ifu) states "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 [0.89 mm] or 0.038 in [0.97 mm] inner lumen) imager ii selective diagnostic catheter without side flushing holes".The use of other diagnostic catheters may result in an inability to deliver, deploy, or recapture the device.The detach, bent and stretched main coil, found during the product analysis, can be attributed to the friction between the catheter and the pushing action of the delivery wire and the main coil, 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 damages, this could possibly have affected the performance and integrity of the device.Hence, the issues found will be classified as "adverse event related to procedure" which indicates that the adverse event occurred during the procedure and the device had no influence on the event, moreover a device history record (dhr) review was conducted and no deviations that could have contributed to the reported event were found.Therefore, all compiled information on this investigation determines that the conclusion cause is unintended use error caused or contributed to event instructions since the interaction between the user and device, or sample, caused or contributed to the error.

• 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: 24618237
• Report Number: 2124215-2026-14612
• Device Sequence Number: 10333911
• Product Code: KRD
• UDI-Device Identifier: 08714729795438
• UDI-Public: (01)08714729795438(17)280325(10)36156382
• 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): 03/17/2026

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: 0036156382
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2026
• Initial Report FDA Received Date: 03/17/2026
• 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
• Patient Age: 36 YR
• Patient Sex: Male
• Patient Weight: 76 KG