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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR REACT CATHETER CATHETER, PERCUTANEOUS

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MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR REACT CATHETER CATHETER, PERCUTANEOUS Back to Search Results
Model Number REACT-71
Device Problems Break (1069); Difficult to Advance (2920); Physical Resistance/Sticking (4012)
Patient Problem Arrhythmia (1721)
Event Date 08/17/2020
Event Type  Injury  
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Event Description

It was reported that the procedure was through the radial access in severe tortuous anatomy in the aortic arch. There was friction/difficulty during delivery, and the navien catheter became broken/ruptured at the distal segment. All access devices went through it to the patient's heart causing a short cardiac arrythmia. Once noticed what happened, they removed access and broken navien and continued the procedure with new access items.

 
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Brand NameREACT CATHETER
Type of DeviceCATHETER, PERCUTANEOUS
Manufacturer (Section D)
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
9775 toledo way
irvine CA 92618
Manufacturer (Section G)
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
9775 toledo way
irvine CA 92618
Manufacturer Contact
tricha miles
9775 toledo way
irvine, CA 92618
7635140379
MDR Report Key10484382
MDR Text Key205483042
Report Number2029214-2020-00877
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeFI
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 12/07/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/02/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberREACT-71
Device Catalogue NumberREACT-71
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/11/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/04/2020
Was Device Evaluated By Manufacturer? Yes
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: 09/02/2020 Patient Sequence Number: 1
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