MAUDE Adverse Event Report: ST. JUDE MEDICAL CARDIOVASCULAR DIVISION ANGIO-SEAL; DEVICE, HEMOSTASIS, VASCULAR

Model Number	EVOLUTION¿
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/12/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Doctor reported the angio-seal device failed to deploy.They also noted a known 5% failure rate with this device.There was no operator error issue, strictly a faulty device.

• Brand Name: ANGIO-SEAL
• Common Device Name: DEVICE, HEMOSTASIS, VASCULAR
• Manufacturer (Section D): ST. JUDE MEDICAL CARDIOVASCULAR DIVISION; 14901 deveau pl.; minnetonka MN 55345
• MDR Report Key: 7929422
• Report Number: 7929422
• Device Sequence Number: 19182430
• Product Code: MGB
• UDI-Device Identifier: 05415067002839
• UDI-Public: (01)05415067002839
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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): 09/25/2018
• Report Date (Section F): 09/25/2018

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: EVOLUTION¿
• Device Catalogue Number: C610134
• Device Lot Number: 6129457
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/03/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/03/2018
• 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: 09/25/2018