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

Model Number	M001363670
Medical Device Problem Codes	Difficult to Remove (1528); Stretched (1601); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 11mar2025.It was reported that the coil was stretched.A 18mm x 40cm 2d interlock-35 coil was selected for use in a hepatic arteriography and transjugular intrahepatic portosystemic shunt procedure.The target location was in the gastric varices.During the procedure, a resistance occurred when delivering the coil, and the coil could not be withdrawn.The coil was then removed with the 5f non-boston scientific contrast catheter.Upon removal, the coil was found to be stretched.The procedure was completed with another of the same device.There were no complications as a result of this event, and the patient was in stable condition following the procedure.However, returned device analysis revealed that the arm of the coil was detached.
Additional Manufacturer Narrative
E1 initial reporter facility name: (b)(6).Device evaluation by manufacturer: the device was returned for analysis.Visual and microscopic inspection observed that the main coil, the introducer sheath, and the delivery wire were returned.The main coil was bent and stretched at the coil arm and primary coil section; moreover, the arm of the coil was detached.Dimensional inspection revealed that the components were within specification.

• 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: 21775352
• Report Number: 2124215-2025-18971
• Device Sequence Number: 9821950
• Product Code: KRD
• UDI-Device Identifier: 08714729795414
• UDI-Public: (01)08714729795414(17)260815(10)32225649
• 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): 04/04/2025

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 Expiration Date: 08/15/2026
• Device Model Number: M001363670
• Device Catalogue Number: M001363670
• Device Lot Number: 0032225649
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2025
• Initial Report FDA Received Date: 04/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2023
• 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: CATHETER: CORDIS 5F
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 70 KG