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

Model Number	83779
Medical Device Problem Codes	Premature Activation (1484); Malposition of Device (2616); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E1 - initial reporter facility name: (b)(6).
Event or Problem Description
It was reported that the coil deployed in an unintended target location, requiring snare for removal.The target location was located in the tortuous coronary artery.A 4mm x 8cm interlock coil was selected for coronary artery fistula embolization.During the procedure, the coil was suddenly released in the catheter.When it was pulled back, the coil was brought to the main trunk, affecting the blood flow of another vessel.A snare was used to remove the coil, and the coil was noted to be deformed.The procedure was completed using a different device.No complications reported, and patient was stable post procedure.
Event or Problem Description
It was reported that the coil deployed in an unintended target location, requiring snare for removal.The target location was located in the tortuous coronary artery.A 4mm x 8cm interlock coil was selected for coronary artery fistula embolization.During the procedure, the coil was suddenly released in the catheter.When it was pulled back, the coil was brought to the main trunk, affecting the blood flow of another vessel.A snare was used to remove the coil, and the coil was noted to be deformed.The procedure was completed using a different device.No complications reported, and patient was stable post procedure.
Additional Manufacturer Narrative
E1 - initial reporter facility name: (b)(6).Device evaluated by mfr: only the pusher wire was returned to our post market quality assurance laboratory.Visual and microscopic inspections were performed, and it was observed that the pusher wire was bent and detached at the heat shrink tfe tubing section.Dimensional inspection of the pusher wire revealed the components were within specifications.

• 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: 20360065
• Report Number: 2124215-2024-61152
• Device Sequence Number: 8126758
• Product Code: KRD
• UDI-Device Identifier: 08714729764953
• UDI-Public: 08714729764953
• 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,Followup
• Report Date (Section B): 11/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/17/2026
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0031643956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2024
• Supplement Date Received by Manufacturer: 11/01/2024
• Initial Report FDA Received Date: 10/03/2024
• Supplement Report FDA Received Date: 11/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/18/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male