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

Model Number	M001363590
Medical Device Problem Codes	Difficult to Remove (1528); 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	04/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - initial reporter facility name: (b)(6) hospital.Device evaluated by mfr: only the main coil was returned for evaluation.Visual and microscope inspections were performed.It was observed that the main coil was bent and stretched at the coil zap tip and primary coil section, moreover the zap tip was detached.Dimensional inspection of the main coil revealed the components were within specification.No other issues were identified during the product analysis.
Event or Problem Description
Reportable based on device analysis completed on 26jun2025.It was reported that coil was unable to advance and unable to be withdrawn from the catheter.The patient was presented with a left internal iliac artery aneurysm.The target lesion was located in the left and right internal iliac arteries.An 8mm x 40cm interlock?-35 was selected for use.During the procedure, a guidewire crossed from the right puncture site to the left internal iliac artery and a non-boston scientific contrast catheter was used for super-selective catheterization to reach the embolization site.When delivering the coil, it was noted that the coil could not be delivered out of the cannula.Several attempts were made but failed to deliver the coil out, nor could it be retracted.The coil was withdrawn with the catheter together.The left brachial artery was punctured, and another 5f125 non-boston scientific contrast catheter was used to reach the embolization site.Another coil was used to complete the procedure.There were no patient complications as a result of this event.However, device analysis revealed detached zap tip.

• 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: 22579811
• Report Number: 2124215-2025-48581
• Device Sequence Number: 18132093
• Product Code: KRD
• UDI-Device Identifier: 08714729793014
• UDI-Public: (01)08714729793014(17)260522(10)31673657
• 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): 07/23/2025

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: 05/22/2026
• Device Model Number: M001363590
• Device Catalogue Number: M001363590
• Device Lot Number: 0031673657
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2025
• Initial Report FDA Received Date: 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2023
• 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: TERUMO
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 65 KG