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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 RIST RADIAL ACCESS GUIDE CATHETER CATHETER, PERCUTANEOUS

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MICRO THERAPEUTICS, INC. DBA EV3 RIST RADIAL ACCESS GUIDE CATHETER CATHETER, PERCUTANEOUS Back to Search Results
Model Number 107F-079-100V01
Device Problems Use of Device Problem (1670); Unintended Movement (3026)
Patient Problems Stroke/CVA (1770); Headache (1880); Intracranial Hemorrhage (1891); Pain (1994); Loss of Range of Motion (2032); Stenosis (2263); Unspecified Nervous System Problem (4426); Thrombosis/Thrombus (4440)
Event Date 01/20/2022
Event Type  Injury  
Event Description
Medtronic received a report that a procedure involving a rist catheter for transradial access was switched to transfemoral access due to not obtaining enough stability and the guiding catheter collapsed to the aortic side. They attempted with different support catheters, but this did not help, so the procedure was switched to the femoral artery. A pipeline was successfully implanted. The patient also experienced a generalized headache and ischemic stroke after the procedure on (b)(6) 2022. This resulted in prolonged hospitalization and neurological deficits lasting more than 24 hours. It was observed that motor function on the right side was not as good as on the left side. On (b)(6) 2022 there was limb pain and suspicion of deep vein thrombosis on the right lower limb, but this resolved the same day without further treatment. The events were noted as recovering/resolving. The adverse events were assessed as related to the device and procedure. The patient was undergoing treatment for a saccular, sidewall aneurysm located in the c6 segment of the left internal carotid artery. The max diameter was 9mm, the dome height was 8mm, the dome width was 5. 6mm, and the neck size was 4mm. The parent artery diameter to the aneurysm was 3. 7mm distal and 4mm proximal. Post implant showed no stasis in the aneurysm, and the raymond and roy occlusion was class 3. Ancillary devices include navien support catheters and a phenom 27 microcatheter.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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Brand NameRIST RADIAL ACCESS GUIDE 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 Key13375587
MDR Text Key284802073
Report Number2029214-2022-00111
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeFI
PMA/PMN Number
K191551
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Study,Health Professional
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 08/16/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/27/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number107F-079-100V01
Device Catalogue Number107F-079-100V01
Device Lot Number17079-01
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/03/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 01/27/2022 Patient Sequence Number: 1
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