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); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that malposition of a device occurred.A 4mm x 8cm interlock was selected for an embolization procedure.During the procedure, however, the coil was released without the radiologist performing the maneuver.This resulted in the coil being released in an unintended location.No interventions or patient complications have been reported despite multiple inquiries.
Additional Manufacturer Narrative
Device evaluation by manufacturer: unit returned with its original pouch batch 33383851.It was observed that the introducer sheath and the pusher wire were returned.It was observed that the pusher wire was bent at the coil section of the device.The functional test could not be performed because the main coil and the pusher wire are not interlocking.Based on the evidence, the as reported code main coil malposition of device cannot be confirmed, since this issue was not found during the product inspection.The as reported code premature deployment inside patient cannot be confirmed since the main coil cannot be functionally evaluated to confirm this type of failure.
Event or Problem Description
It was reported that malposition of a device occurred.A 4mm x 8cm interlock was selected for an embolization procedure.During the procedure, however, the coil was released without the radiologist performing the maneuver.This resulted in the coil being released in an unintended location.No interventions or patient complications have been reported despite multiple inquiries.

• 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: 20559843
• Report Number: 2124215-2024-67059
• Device Sequence Number: 3114118
• Product Code: KRD
• UDI-Device Identifier: 08714729764953
• UDI-Public: 08714729764953
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2025

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 Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0033383851
• 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: 10/03/2024
• Supplement Date Received by Manufacturer: 12/25/2024
• Initial Report FDA Received Date: 10/29/2024
• Supplement Report FDA Received Date: 01/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/08/2024
• 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: Unknown