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

Model Number	M001363630
Medical Device Problem Codes	Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device analysis by manufacturer: this interlock-35 main coil, introducer sheath and delivery wire were returned for analysis.Visual and microscopic inspection identified that the main coil was bent and stretched at the primary coil section, moreover the arm coil was detached.
Event or Problem Description
Reportable based on device analysis completed on 24nov2025.It was reported the device was unable to withdraw from the catheter.A 2d.035 12mm x 40cm interlock-35 device was selected for an embolization procedure to treat for use in a pelvic congestion syndrome (pcs).During the procedure, the coil became difficult to remove from inside of the catheter.A different device of the same model was used to complete the procedure.There were no patient complications as a result of this event.However, microscopic device analysis revealed the main coil of the device was detached/separated, bent and stretched.In addition, the arm coil was noted to be detached/separated.

• 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: 23744833
• Report Number: 2124215-2025-89610
• Device Sequence Number: 8449266
• Product Code: KRD
• UDI-Device Identifier: 08714729792970
• UDI-Public: (01)08714729792970(17)271212(10)35476227
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/08/2025

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 Model Number: M001363630
• Device Catalogue Number: M001363630
• Device Lot Number: 0035476227
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2025
• Initial Report FDA Received Date: 12/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2024
• 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 Sex: Unknown