MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR MARKSMAN CATHETER; CATHETER, CONTINUOUS FLUSH

Model Number FA-55160-1030

Device Problems Migration or Expulsion of Device (1395); Difficult to Remove (1528); Detachment of Device or Device Component (2907); Infusion or Flow Problem (2964)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 01/06/2019

Event Type  Injury  

Event Description

During right middle cerebral artery (mca) thrombectomy, tip of catheter detached/embolized resulting in no significant flow distal to the catheter tip.Clot and catheter tip were not retrieved.Patient developed subarachnoid and intraparenchymal hemorrhages post procedure.Manufacturer response for ev3# marksman catheter, ev3# marksman catheter (per site reporter): rep notified, not aware of similar events.

• Brand Name: MARKSMAN CATHETER
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR; 710 medtronic parkway; minneapolis MN 55432 5604
• MDR Report Key: 8247918
• MDR Text Key: 133070485
• Report Number: 8247918
• Device Sequence Number: 1
• Product Code: KRA
• 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: 01/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FA-55160-1030
• Device Catalogue Number: FA-55160-1030
• Device Lot Number: 216326976
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/07/2019
• Event Location: Hospital
• Date Report to Manufacturer: 01/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 30295 DA
• Patient Weight: 60