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

Model Number	83779
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	08/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 30oct2024.It was reported that the coil prematurely deployed inside the catheter.A 14mm x 20cm interlock was selected for use in a splenic artery embolization.During the procedure, the interlocking arm disengaged prematurely inside the stc-18 microcatheter and could not be pushed forward.The whole delivery system was withdrawn together with the coil, and the procedure was completed with another of the same device.No complications were reported, and the patient was stable post procedure.However, device analysis revealed that the main coil was detached from the arm of the coil.
Additional Manufacturer Narrative
Device eval by manufacturer: only the main coil was returned.It was observed that the main coil was detached, bent, and stretched at the coil arm, primary coil and zap tip section.Functional testing could not be performed since the main coil and the pusher wire were not interlocking.Dimensional inspection of the returned components revealed they were within specifications.No other issues were identified with the device.

• 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: 20758967
• Report Number: 2124215-2024-70719
• Device Sequence Number: 15773677
• Product Code: KRD
• UDI-Device Identifier: 08714729765066
• UDI-Public: 08714729765066
• 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): 11/22/2024

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: 03/21/2026
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0031470218
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2024
• Initial Report FDA Received Date: 11/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/21/2023
• 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 Sex: Female