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

Model Number	M001363670
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	04/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter facility name: (b)(6).The device was returned for detailed analysis.Upon examination, both the main coil and the introducer sheath were identified as part of the returned components.In order to facilitate the removal of the coil, it was necessary to make an incision in the introducer wire.Further inspection revealed that the main coil exhibited significant deformation, characterized by bending and stretching at both the coil arm and primary coil sections.Additionally, the arm coil was found to be detached from the main assembly.The main coil itself was detached, exhibiting signs of bending and stretching.The coil dimensions that could be measured were inspected against the drawing: assy,.035 interlock 2d coil, 90610715, primary coil winding specification, m310886-00, and 90589292, coil arm, bsc.
Event or Problem Description
Reportable based on the device analysis completed in 12jun2025.It was reported that the coil was unable to advance.The stenosed target lesion was located in the aorta.A 18mm x 40cm interlock device was selected for use.During the procedure, multiple attempts were made to advance the coil through the catheter; however, the coil failed to exit the catheter as intended.The procedure was completed using with another of the same device.There were no patient complications as a result of this event.However, returned device analysis revealed main coil 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: 22472915
• Report Number: 2124215-2025-44810
• Device Sequence Number: 19901801
• Product Code: KRD
• UDI-Device Identifier: 08714729795414
• UDI-Public: (01)08714729795414(17)270503(10)33958066
• 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): 07/10/2025

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: M001363670
• Device Catalogue Number: M001363670
• Device Lot Number: 0033958066
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2025
• Initial Report FDA Received Date: 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2024
• 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
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 75 KG