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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-71
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fever (1858); Intracranial Hemorrhage (1891); Unspecified Nervous System Problem (4426)
Event Date 04/27/2021
Event Type  Injury  
Manufacturer Narrative

Patient clinical id: (b)(6). If information is provided in the future, a supplemental report will be issued.

 
Event Description

Medtronic received a report that there was hemorrhagic transformation cerebral (ph1) with fever and it was conservatively treated. The adverse event was resolved 2021-04-29 with unspecified sequelae and disability. There was no device deficiency reported, and it was assessed the event was possibly related to the device and procedure. The patient was undergoing surgery for thrombectomy in the left middle cerebral artery (mca) m1. Modified rankin scale (mrs) score was 3,and national institutes of health stroke scale (nihss) was 20. Pre-procedure modified thrombolysis in cerebral infarction (mtici) was 0, and post-procedure mtici was 3.

 
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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 Key11831620
MDR Text Key251194507
Report Number2029214-2021-00578
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeSZ
PMA/PMN NumberK182097
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 07/12/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/17/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberREACT-71
Device Catalogue NumberREACT-71
Device LOT NumberA970150
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/01/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured02/03/2020
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: 05/17/2021 Patient Sequence Number: 1
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