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

Model Number	M001363610
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	03/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 11jun2025.It was reported that the coil could not be pushed out.The target lesion was located in the abdominal aorta and left internal iliac artery.A 10mm x 40cm interlock-35 was selected for interventional embolization.During the procedure, the guide wire was used to cross the right puncture port to the left internal iliac artery.After the guide wire was in place, the non-boston scientific angiography catheter was used to reach the embolization position.However, when the coil was pushed normally, the coil could not be pushed out of the outer sheath.The physician tried several times but could not push the coil out.The procedure was completed with another of the same device.There were no patient complications as a result of this event.However, device analysis revealed the arm coil was detached.
Additional Manufacturer Narrative
E1 - initial reporter address 1: no.(b)(6).Device evaluated by mfr: the complaint device was returned to our post market quality assurance laboratory.Visual inspection was performed and it was observed that the main coil and the introducer sheath were returned.It was necessary to make a cut in the introducer wire to remove the coil.It was observed that the main coil was bent and stretched at the coil arm and primary coil section, moreover the arm coil was detached.Microscopic inspection revealed the main coil was detached, bent and stretched.Dimensional inspection of the main coil revealed the components were within specifications.No other issues were identified during the product analysis.

• 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: 22437241
• Report Number: 2124215-2025-44287
• Device Sequence Number: 16934809
• Product Code: KRD
• UDI-Device Identifier: 08714729793168
• UDI-Public: 08714729793168
• 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): 07/08/2025

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: 07/18/2026
• Device Model Number: M001363610
• Device Catalogue Number: M001363610
• Device Lot Number: 0032045133
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2025
• Initial Report FDA Received Date: 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/19/2023
• 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: CATHETER - CORDIS 5F
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 56 KG