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U.S. Department of Health and Human Services

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

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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 Hemorrhage/Bleeding (1888); Cognitive Changes (2551)
Event Date 04/30/2021
Event Type  Injury  
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Event Description

Medtronic received a report that the patient experienced post procedure intraventricular hemorrhage due to hemorrhagic transformation and neurological deficit resulting in prolonged hospitalization. The patient was released from the hospital on (b)(6) 2021 and is recovering/resolving. The patient's intraventricular hemorrhage was noted to have a causal relationship to the procedure and was not related to the device itself. The neurological deterioration was noted to be due to general anesthesia associated with respiratory failure, mechanical ventilation, and sedation. The patient's mrs score was 0 and nihss score 14. The patient was undergoing treatment of a left ica clot, middle mca m2 clot. Pre-procedure mtici was 0, post procedure 2b.

 
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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
david gustafson
9775 toledo way
irvine, CA 92618
7635149628
MDR Report Key11960099
MDR Text Key265203974
Report Number2029214-2021-00697
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeAR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,S
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 09/02/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/08/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberREACT-68
Device Catalogue NumberREACT-68
Device LOT NumberB101536
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/04/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured10/13/2020
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: 06/08/2021 Patient Sequence Number: 1
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