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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); Intracranial Hemorrhage (1891); Swelling/ Edema (4577)
Event Date 04/24/2021
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 ct imaging 24 hours a solitaire procedure showed radiographic mass effect with 2mm midline shift, subarachnoid hemorrhage, parenchymatous hematoma (ph1), and intraventricular hemorrhage (ivh). On (b)(6) 2021, ct imaging showed expansion of the index of infarction, radiographic mass effect with midline shift of 3mm, and ph1.  there were no issues with the devices. The patient status was alive with no injury.  the patient did not experience any symptoms or other complications. Patient medical history included hypertension. Additional information received reported there was no additional medical or surgical intervention performed. Additional information received reported the adverse events resulted in prolonged hospitalization of the patient who was discharged on (b)(6) 2021. The events were noted to result in unspecified patient disability and the patient was noted to be recovering and events resolving at time of discharge. Information regarding the intraventricular hemorrhage indicated that unspecified medical interve ntion was administered.

 
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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 Key11940813
MDR Text Key254554695
Report Number2029214-2021-00675
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,Followup
Report Date 09/29/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/04/2021
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 Received09/06/2021
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: 06/04/2021 Patient Sequence Number: 1
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