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

Model Number	M001361930
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	07/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - initial reporter facility name: (b)(6).E1 - initial reporter phone: device evaluated by mfr: the pe f-idc device was returned to our post market quality assurance laboratory.Visual inspection was performed and revealed that only the main coil was returned.It was observed that the main coil was bent and stretched at the primary coil section, moreover the arm coil was detached.Microscopic examination identified that the main coil was detached, bent and stretched.Dimensional inspection of the main coil revealed the components were within specifications.Media inspection revealed that there is a picture attached in the parent record, and it was possible to observe that the main coil was stretched.
Event or Problem Description
Reportable based on device analysis completed on 05nov2025.It was reported that the coil could not be advanced from the catheter.The target lesion was located in the pulmonary artery.A 14mm x 50cm pe f-idc coil was selected for pulmonary embolism.During the procedure, the coil was stuck in the catheter and could not be pushed out of the catheter despite multiple attempts.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 a detached, bent and stretched main coil.

• Brand Name: INTERLOCK?
• 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: 23695340
• Report Number: 2124215-2025-85786
• Device Sequence Number: 21390184
• Product Code: KRD
• UDI-Device Identifier: 08714729845294
• UDI-Public: (01)08714729845294(17)271002(10)35195644
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K132578
• 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): 12/02/2025

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: M001361930
• Device Catalogue Number: M001361930
• Device Lot Number: 0035195644
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2025
• Initial Report FDA Received Date: 12/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2024
• 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: 52 YR
• Patient Sex: Male
• Patient Weight: 65 KG