MAUDE Adverse Event Report: MEDTRONIC, INC.; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Device Problem Insufficient Information (3190)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/16/2022

Event Type  No Answer Provided  

Event Description

Mid 40¿s woman with left vertebral artery dissection and basilar occlusion.Patient presented for cerebral angiography and mechanical thrombectomy.Mri on the following day identified a focal area of susceptibility in the right occipital lobe.Mri confirmed artifact.

• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): MEDTRONIC, INC.; 710 medtronic pkwy.; minneapolis MN 55432
• MDR Report Key: 14564552
• MDR Text Key: 293102914
• Report Number: 14564552
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/16/2022,04/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/16/2022
• Event Location: Hospital
• Date Report to Manufacturer: 06/01/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1