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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 Stroke/CVA (1770); Hematoma (1884); Intracranial Hemorrhage (1891); Swelling/ Edema (4577)
Event Date 01/10/2022
Event Type  Death  
Manufacturer Narrative
Related regulatory report: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received a report that the patient had hematoma within an ischemic field with mild space-occupying effect involving less than or equal to 30% of the infarcted area (ph1). The stroke onset to reperfusion time was (b)(6) 2022 at 10:40 with re-profusion 19:50.
 
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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
glen belmer
9775 toledo way
irvine, CA 92618
6122713209
MDR Report Key13434612
MDR Text Key284959614
Report Number2029214-2022-00144
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K182097
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Study,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 08/15/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/02/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberREACT-71
Device Catalogue NumberREACT-71
Device Lot NumberB237017
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received08/08/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/20/2021
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: 02/02/2022 Patient Sequence Number: 1
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