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

Model Number	83779
Medical Device Problem Codes	Difficult to Advance (2920); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was cancelled.The patient was being treated for aneurysm in the moderately tortuous hepatic artery.A 20mm x 50cm interlock was selected for use in the embolization procedure.However, during the procedure, the coil was stuck in the delivery sheath as there was resistance, and the coil could not advance past the non-boston scientific catheter hub.It was noted that the twist lock was fully opened, the introducer sheath was firmly seated in the hub of the catheter before an attempt was made to retract the coil, and continuous flushing was performed.The procedure was postponed.No patient complications were reported.
Event or Problem Description
It was reported that the procedure was cancelled.The patient was being treated for aneurysm in the moderately tortuous hepatic artery.A 20mm x 50cm interlock was selected for use in the embolization procedure.However, during the procedure, the coil was stuck in the delivery sheath as there was resistance, and the coil could not advance past the non-boston scientific catheter hub.It was noted that the twist lock was fully opened, the introducer sheath was firmly seated in the hub of the catheter before an attempt was made to retract the coil, and continuous flushing was performed.The procedure was postponed.No patient complications were reported.
Additional Manufacturer Narrative
Unit was returned with its original pouch, and overall visual inspection did not identify failures or evidence that could be lost due to decontamination process.It was observed that the main coil, the introducer sheath and the pusher wire were returned.It was necessary to make a cut in the introducer sheath to remove the coil.Visual and microscopic inspection found that the main coil was bent and stretched at the primary coil section.The pusher wire was kinked and stretched at heat shrink tfe tubing and coil section, moreover the coil section was 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: 19208644
• Report Number: 2124215-2024-20950
• Device Sequence Number: 15435681
• Product Code: KRD
• UDI-Device Identifier: 08714729845317
• UDI-Public: 08714729845317
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2025

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 Expiration Date: 04/10/2026
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0031597621
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/03/2024
• Supplement Date Received by Manufacturer: 08/11/2025
• Initial Report FDA Received Date: 04/29/2024
• Supplement Report FDA Received Date: 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/11/2023
• 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: MICROCATHETER: DIREXION TRANSEND; MICROCATHETER: DIREXION TRANSEND
• Patient Age: 51 YR
• Patient Sex: Female
• Patient Weight: 25 KG
• Patient Race: Asian