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

Model Number	M001363670
Medical Device Problem Codes	Failure to Advance (2524); Difficult to Advance (2920); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - initial reporter facility name: (b)(6).E1 - initial reporter address 1: (b)(6).Device evaluated by mfr: the main coil, the introducer sheath, and the pusher wire were returned to our post market quality assurance laboratory.Visual and microscopic inspections were performed, and it was observed that the main coil was bent and stretched at the primary coil and arm coil section.Moreover, the arm coil was detached.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 25nov2024.It was reported that the coil could not advance in the catheter.The patient diagnosed with a left common iliac artery aneurysm, underwent treatment with endovascular stent-graft repair.An 18mm x 40cm interlock-35 coil and a non-boston scientific (bsc) catheter was selected for embolization.However, during the procedure, the physician felt significant resistance when deploying the coil.After several attempts, the catheter was replaced but the coil could still not be pushed out.The device was removed, and the procedure was completed with another of the same device.The patient's condition following the procedure was stable.However, device analysis revealed that the arm 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: 20894380
• Report Number: 2124215-2024-77975
• Device Sequence Number: 8710307
• Product Code: KRD
• UDI-Device Identifier: 08714729795414
• UDI-Public: 08714729795414
• 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): 12/10/2024

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: 09/12/2026
• Device Model Number: M001363670
• Device Catalogue Number: M001363670
• Device Lot Number: 0032416411
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2024
• Initial Report FDA Received Date: 12/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/13/2023
• 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 - 5F CORDIS.
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 56 KG