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

Model Number	M001363630
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Device evaluation by manufacturer: only the main coil was returned for analysis.Visual and microscopic inspections revealed that the coil was bent and stretched at the coil arm and primary coil section; moreover, the arm of the coil was detached.Dimensional inspection was performed, and the main coil was within specifications.
Event or Problem Description
Reportable based on device analysis completed on 04mar2025.It was reported that the coil could not be delivered.A 12mm x 40cm interlock-35 2d coil was selected for use in a transjugular intrahepatic portosystemic shunt (tips) procedure.The target location was a splenic aneurysm.Continuous flushing was performed as the coil was advanced through a non-boston scientific radiography catheter.However, the coil could not be pushed forward despite repeated attempts.The procedure was completed with another of the same device.There were no patient complications as a result of this event, and the patient condition following the procedure was stable.However, returned device analysis revealed 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: 21719941
• Report Number: 2124215-2025-17324
• Device Sequence Number: 14418638
• Product Code: KRD
• UDI-Device Identifier: 08714729792970
• UDI-Public: (01)08714729792970(17)250817(10)29977736
• 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): 03/28/2025

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: 08/17/2025
• Device Model Number: M001363630
• Device Catalogue Number: M001363630
• Device Lot Number: 0029977736
• 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: 03/04/2025
• Initial Report FDA Received Date: 03/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/18/2022
• 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: DIAGNOSTIC CATHETER: COOK
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 62 KG