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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 Hematoma (1884); Hemorrhage/Bleeding (1888); Unspecified Nervous System Problem (4426); Swelling/ Edema (4577)
Event Date 04/30/2021
Event Type  Injury  
Manufacturer Narrative

Patient date of birth - only the year of patient's birth was reported. Therefore, only the year of the reported patient date-of-birth in this record is valid. If information is provided in the future, a supplemental report will be issued.

 
Event Description

Medtronic received information reporting that 24-hour post-procedure following a procedure in which a solitaire and a react-68 catheter were used without issue, computed tomography (ct) revealed radiographic hematoma occupying 30% or more of the infarcted tissue with mass effect with 6mm midline shift (ph2) and intraventricular hemorrhage. The patient had neurological deterioration greater than or equal to 4 points from baseline nihss. It was unknown if any additional medical and surgical treatment was required.

 
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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 Key11894880
MDR Text Key254025776
Report Number2029214-2021-00629
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeAR
PMA/PMN NumberK180715
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
Report Date 06/22/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/27/2021
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? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/31/2021
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: 05/27/2021 Patient Sequence Number: 1
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