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

Model Number	M001363800
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 initial reporter facility name: (b)(6).Device evaluation by manufacturer: the device was returned for analysis.The main coil, the introducer sheath, and the delivery wire were returned.Visual and microscopic inspection revealed that the main coil was bent and stretched at the coil arm and primary coil; moreover, the arm of the coil was detached.Dimensional inspection was performed, and the coil was within specification.
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2025.It was reported that the coil could not be withdrawn.A 10mm x 40cm interlock-35 coil was selected for use in an embolization procedure in the internal iliac artery.The coil was advanced through a 5f non-boston scientific catheter.However, the position of the coil was not good.Upon attempted removal, it was found that the coil could not be withdrawn.The coil was then removed together with the catheter.The device was exchanged for another of the same coil type, and the coil was deployed successfully.There were no patient complications as a result of this event.The patient condition following the procedure was stable.However, device analysis revealed that the coil arm 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: 21655018
• Report Number: 2124215-2025-15175
• Device Sequence Number: 18012466
• 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): 03/20/2025

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: 07/25/2026
• Device Model Number: M001363800
• Device Catalogue Number: M001363800
• Device Lot Number: 0032089583
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2025
• Initial Report FDA Received Date: 03/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/26/2023
• 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: 5F CORDIS.
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 69 KG