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

Model Number	M001361500
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/21/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Coil detached before being placed in the desired location during an embolization.

• Brand Name: INTERLOCK
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11805381
• Report Number: 11805381
• Device Sequence Number: 17229644
• Product Code: KRD
• UDI-Device Identifier: 08714729764939
• UDI-Public: (01)08714729764939(17)211225(10)23243395
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 05/03/2021
• Report Date (Section F): 05/03/2021

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: M001361500
• Device Catalogue Number: M001361500
• Device Lot Number: 23243395
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/11/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 05/03/2021