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

Model Number	M001363800
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: the main coil, the introducer sheath, and the delivery wire were returned for analysis.Visual and microscopic inspections were performed, and it was observed that the main coil was bent and stretched at the coil arm and the primary coil section.Moreover, the arm of the coil was detached.Functional testing could not be performed since the main coil and the delivery wire were not interlocking.Dimensional inspection of the main coil revealed the components were within specifications.
Event or Problem Description
Reportable based on device analysis completed on 24feb2025.It was reported that the coil was unable to advance.A 10mm x 40cm, interlock-35 was selected for use in the embolization of a splenic aneurysm.During the procedure, the coil was delivered using a non-boston scientific (bsc) catheter.Heparin saline infusion was performed throughout, with continuous flushing, which was performed prior to coil introduction.However, it was noted that the coil could not continue advancing at the distal end of the catheter even after repeated attempts.The coil was removed from the patient's body, and the procedure was completed with another of the same device.There were no patient complications as a result of this event, and the patient's condition following the procedure was stable.However, device analysis revealed the arm of the coil was detached.

• 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: 21680274
• Report Number: 2124215-2025-17810
• Device Sequence Number: 20895340
• Product Code: KRD
• UDI-Device Identifier: 08714729795513
• UDI-Public: 08714729795513
• 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): 03/24/2025

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: M001363800
• Device Catalogue Number: M001363800
• Device Lot Number: 0033707381
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2025
• Initial Report FDA Received Date: 03/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/26/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CATHETER - JOHNSON & JOHNSON 4F
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 80 KG