• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 REACT CATHETER CATHETER, PERCUTANEOUS

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MICRO THERAPEUTICS, INC. DBA EV3 REACT CATHETER CATHETER, PERCUTANEOUS Back to Search Results
Model Number REACT-68
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Intracranial Hemorrhage (1891); Unspecified Nervous System Problem (4426)
Event Date 01/07/2022
Event Type  Injury  
Event Description
Medtronic received a report that a patient underwent a thrombectomy procedure with a solitaire stent retriever and react-68 catheter. Post-procedure the nihss was 18 and the presence of neurological deterioration at 24 hours. There was a greater than 4 point worsening from the baseline nihss 6. No patient symptoms were reported. The patient was being treated for an ischemic stroke in the middle cerebral artery, m2. The stroke onset was 19:00 on (b)(6) 2022 and the reperfusion 2as 23:05 on (b)(6) 2022. The patient's mrs score baseline was 0 and procedure was 1. The patient's nihss score baseline was 6 and post-procedure was 18. The tici score baseline was 2b and post-procedure was 3. The iv tpa was not contraindicated and there were 2 passes with the device.
 
Manufacturer Narrative
This event is reported conservatively for patient injury due to the significant increase in the patient's post-procedure nihss score from baseline. The procedure was successful based on patient tici score and no report of malfunction or patient symptoms. If information is provided in the future, a supplemental report will be issued.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameREACT CATHETER
Type of DeviceCATHETER, PERCUTANEOUS
Manufacturer (Section D)
MICRO THERAPEUTICS, INC. DBA EV3
9775 toledo way
irvine CA 92618
Manufacturer (Section G)
MICRO THERAPEUTICS, INC. DBA EV3
9775 toledo way
irvine CA 92618
Manufacturer Contact
glen belmer
9775 toledo way
irvine, CA 92618
6122713209
MDR Report Key13509360
MDR Text Key288378526
Report Number2029214-2022-00196
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
K180715
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Study,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 05/09/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/10/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberREACT-68
Device Catalogue NumberREACT-68
Device Lot NumberB274448
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/28/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured09/30/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/10/2022 Patient Sequence Number: 1
-
-