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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 Problems Deformation Due to Compressive Stress (2889); Material Deformation (2976)
Patient Problem Intracranial Hemorrhage (1891)
Event Date 01/05/2021
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 there was difficult navigation with a phenom 27 catheter, a solitaire had resistance in a phenom 21 catheter, and a react 71 catheter kinked. The patient was undergoing treatment for a large vessel occlusion stroke thrombectomy. The patient¿s vessel tortuosity was normal. The access vessel was the ica. It was reported that with the phenom 27 there was difficult navigation and it would not advance distally. The phenom 27 was removed, and a phenom 21 was advanced in place of it. The solitaire was delivered through the phenom 21 but there was strong resistance in the distal segment. The phenom was removed after delivering the solitaire. No damage was observed to either the phenom 27 or phenom 21. The solitaire was then retracted under aspiration into the react 71. Upon retraction of the react 71 the catheter was observed to kink, accordion, and had the appearance of separation in the proximal body of the catheter. The catheter was fully removed under aspiration. Upon inspection on the table the catheter appeared normal in appearance. The solitaire also appeared normal in appearance. The devices were prepared according to the instructions for use (ifu). It was reported that there was a subarachnoid hemorrhage after the case. The doctor stated that in their opinion it was not due to any specific device issue. Ancillary devices include a neuron max sheath and. 014 transcend guidewire.
 
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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 Key11137241
MDR Text Key226874081
Report Number2029214-2021-00027
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K182097
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/07/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberREACT-71
Device Catalogue NumberREACT-71
Device Lot NumberB030267
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 Received02/16/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured05/26/2020
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: 01/07/2021 Patient Sequence Number: 1
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