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	11/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on the device analysis completed on 26feb2026.It was reported that the coil was unable to advance in catheter.The target lesion was located in the moderately tortuous internal iliac artery.An 8mm x 40cm interlock - 35 was selected for use.During the procedure, the coil became stuck in the distal portion of the catheter and could not be advanced.The coil and catheter were removed together, and 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 main coil detachment.
Additional Manufacturer Narrative
Device evaluation by manufacturer: the device was returned for analysis.It was observed that the main coil, introducer sheath, and delivery wire were returned.Examination revealed that the main coil was bent and stretched at the primary coil section, with the arm coil detached.Additionally, the delivery sheath was bent, stretched, and detached at the interlocking arm.Dhr (device history record) 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.Labeling review: review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Risk review: a risk review for the interlock 35 confirmed that events main coil unable to advance in catheter, main coil bent/kinked, detached/separated, stretched, and wire delivery bent/kinked are defined in the risk documentation and recorded in the prr.These events were considered during product risk analysis and are within the acceptable risk-benefit profile for the device.Conclusion: based on a thorough review of the complaint, the most probable cause was unintended use error caused or contributed to event instructions, as a parent 60 catheter was used instead of the recommended imager ii.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: 24706013
• Report Number: 2124215-2026-16692
• Device Sequence Number: 18751814
• Product Code: KRD
• UDI-Device Identifier: 08714729793014
• UDI-Public: (01)08714729793014(17)280330(10)36188636
• 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): 03/26/2026

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: 0036188636
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2026
• Initial Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/31/2025
• 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 Sex: Unknown