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

Model Number	M001363630
Medical Device Problem Codes	Nonstandard Device (1420); 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	07/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 15oct2025.It was reported that the coil could not be pushed out and became damaged.A 12mm x 40cm interlock.035 coil was selected for embolization of an internal iliac artery aneurysm.During the procedure, the coil became stuck in the catheter and could not be pushed out.Upon removal, it was noted that the coil was damaged.The procedure was completed with another of same device.There were no patient complications as a result of this event, and the patient was stable post-procedure.However, device analysis revealed that the arm of the coil was detached.
Additional Manufacturer Narrative
E1 - initial reporter address 1: (b)(6).E1 - initial reporter phone: (b)(6).Device evaluated by mfr: the main coil and the delivery wire were returned for analysis.Visual and microscopic inspections were performed, and it was observed that the main coil was bent and stretched at the primary coil section; moreover, the arm of the coil was detached.Dimensional inspection of the main coil and delivery wire revealed the components were within specification.No other issues were identified during the product analysis.
Additional Manufacturer Narrative
A1 - patient identifier: added.E1 - initial reporter address 1: (b)(6).Device evaluated by mfr: the main coil and the delivery wire were returned for analysis.Visual and microscopic inspections were performed, and it was observed that the main coil was bent and stretched at the primary coil section; moreover, the arm of the coil was detached.Dimensional inspection of the main coil and delivery wire 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 15oct2025.It was reported that the coil could not be pushed out and became damaged.A 12mm x 40cm interlock.035 coil was selected for embolization of an internal iliac artery aneurysm.During the procedure, the coil became stuck in the catheter and could not be pushed out.Upon removal, it was noted that the coil was damaged.The procedure was completed with another of same device.There were no patient complications as a result of this event, and the patient was stable post-procedure.However, device analysis revealed that the arm of the coil 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: 23536820
• Report Number: 2124215-2025-81549
• Device Sequence Number: 13046574
• Product Code: KRD
• UDI-Device Identifier: 08714729792970
• UDI-Public: (01)08714729792970(17)270608(10)34198231
• 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,Followup
• Report Date (Section B): 02/19/2026

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: M001363630
• Device Catalogue Number: M001363630
• Device Lot Number: 0034198231
• 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: 10/15/2025
• Supplement Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 11/12/2025
• Supplement Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/08/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CATHETER - 5F COBRA CATHETER; CATHETER - 5F COBRA CATHETER
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 69 KG