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

Model Number	M001363820
Medical Device Problem Codes	Nonstandard Device (1420); Difficult to Remove (1528); Stretched (1601); 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	12/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - initial reporter phone: (b)(6).Device evaluated by mfr: the main coil was returned for evaluation.It was observed that the main coil was bent along the primary coil and stretched at the coil arm section.Additionally, the coil arm was detached.The device was inspected under magnification, and it was possible to see that the main coil was bent along the primary coil and stretched at the coil arm section.Also, that the coil arm was detached.Dimensional inspection of the main coil 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Reportable based on device analysis completed on 30jan2026.It was reported that the coil could not be advanced and withdrawn from the catheter.The patient presented with liver cirrhosis and upper gastrointestinal bleeding.A 15mm x 40cm interlock?-35 was selected for use in a transjugular intrahepatic portosystemic shunt (tips) and variceal embolization.During the procedure, a y-valve was connected, and continuous flushing with heparinized normal saline was performed.Upon inserting the coil into the non-bsc catheter, the coil was stuck in the catheter and could not be removed.After repeated attempts, it still could not be withdrawn.The coil was removed together with the catheter from the body, and the coil was found stretched.The procedure was completed with another of the same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 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: 24457823
• Report Number: 2124215-2026-10789
• Device Sequence Number: 21158174
• Product Code: KRD
• UDI-Device Identifier: 08714729795438
• UDI-Public: (01)08714729795438(17)260201(10)30973608
• 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): 02/26/2026

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 Expiration Date: 02/01/2026
• Device Model Number: M001363820
• Device Catalogue Number: M001363820
• Device Lot Number: 0030973608
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2026
• Initial Report FDA Received Date: 02/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2023
• 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: MICROCATHETER: CORDIS C2
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 61 KG