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

Model Number	M001361510
Medical Device Problem Codes	Premature Activation (1484); 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	10/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - (b)(6).The device was returned for analysis in a generic plastic bag.Overall visual inspection did not identify any external damage or evidence that may have been compromised by the decontamination process.Upon examination, the main coil and a portion of the pusher wire were found inside the rhv.The main coil and part of the pusher wire were observed to be lodged and damaged within the rhv, and the pusher wire was returned in a detached condition.
Event or Problem Description
Reportable based on the device analysis completed on 5dec2025.It was reported that unable to advance in catheter occurred.The stenosed target lesion was located in the coronary arteriovenous fistula.A 3mm x 12cm interlock was selected for use.During the procedure, coil could not be advanced through the stc18 microcatheter despite multiple attempts and flushing.The physician attempted to withdraw the coil, it became detached within the delivery system and could not be retracted into the protective sheath at the y-valve.The coil was replaced with another device of the same type, and the procedure was completed successfully.There were no patient complications as a result of this event.However, returned device analysis revealed pusher wire detached.

• Brand Name: INTERLOCK?
• 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: 23849733
• Report Number: 2124215-2025-91873
• Device Sequence Number: 9958248
• Product Code: KRD
• UDI-Device Identifier: 08714729764946
• UDI-Public: (01)08714729764946(17)270617(10)34449301
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K132578
• 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): 12/19/2025

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: M001361510
• Device Catalogue Number: M001361510
• Device Lot Number: 0034449301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2025
• Initial Report FDA Received Date: 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/17/2024
• 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: 61 YR
• Patient Sex: Female
• Patient Weight: 50 KG