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

Model Number	83786
Medical Device Problem Codes	Premature Activation (1484); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: the main coil and the pusher wire were received for analysis.A visual and microscopic inspections were performed, and it was observed that the main coil was bent and stretched at the coil arm and primary coil section; moreover, the arm of the coil was detached.Functional testing could not be performed since the main coil and the pusher wire were not interlocking.Dimensional inspection of the main coil revealed the components were within specifications.No other issues were identified during the product analysis.
Event or Problem Description
Reportable based on device analysis completed on 23oct2024.The patient underwent transjugular intrahepatic portosystemic shunt (tips) combined with embolization in the gastric fundus vein.A 10mm x 40cm interlock.035 coil was selected together with a non-boston scientific (bsc) angiography catheter.During the procedure, the coil could not advance forward despite several attempts made.After withdrawing and continuously pushing it, it could not be pushed.After the coil was removed, it was found that the coil had already deployed in the catheter.The procedure was completed with an 8mm x 20cm interlock coil.No patient complications were reported, and the patient was stable post-procedure.However, device analysis revealed that the arm of the coil 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: 20698981
• Report Number: 2124215-2024-67445
• Device Sequence Number: 3850561
• Product Code: KRD
• UDI-Device Identifier: 08714729793168
• UDI-Public: 08714729793168
• 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): 11/15/2024

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: 11/09/2025
• Device Model Number: 83786
• Device Catalogue Number: 83786
• Device Lot Number: 0030516812
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2024
• Initial Report FDA Received Date: 11/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/10/2022
• 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: CATHETER - COOKE
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 69 KG