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

Model Number	83779
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device eval by manufacturer: it was observed that only the pusher wire was returned for analysis.It was observed that the pusher wire was bent and stretched at the coil, heat shrink tfe tubing, and proximal section.Functional testing could not be performed since the main coil was not returned.Dimensional inspection of the returned pusher wire was performed, and the pusher wire was within specifications.The reported break could not be confirmed since the coil was not returned.
Event or Problem Description
It was reported that the tip was fractured.The target lesion was located in the lower extremity veins.A 14mm x 30cm interlock coil was selected for iliac aneurysm embolization.During the procedure, a 5f catheter was used and heparin saline infusion was performed manually, and the flushing was performed prior to coil introduction.However, it was noted that the coil could not be advanced inside the catheter due to resistance.After forced withdrawal, manual heparin saline infusion was performed and then the microcatheter was re-entered, but the coil still could not be advanced.Consequently, it was noted that the tip was fractured upon withdrawal.The procedure was completed with another of the same device.The patient's condition following the procedure was stable.

• Brand Name: INTERLOCK
• 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: 20832950
• Report Number: 2124215-2024-73908
• Device Sequence Number: 8865522
• Product Code: KRD
• UDI-Device Identifier: 08714729765073
• UDI-Public: 08714729765073
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K132578
• 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): 12/03/2024

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: 08/15/2026
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0032435616
• 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: 11/04/2024
• Initial Report FDA Received Date: 12/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2023
• 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
• Patient Age: 78 YR
• Patient Sex: Female