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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 RIST 071 RADIAL ACCESS GUIDE CATHETER CATHETER, PERCUTANEOUS

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MICRO THERAPEUTICS, INC. DBA EV3 RIST 071 RADIAL ACCESS GUIDE CATHETER CATHETER, PERCUTANEOUS Back to Search Results
Model Number 107F-079-105V01
Device Problem Difficult to Advance (2920)
Patient Problems Stroke/CVA (1770); Dysphasia (2195); Vascular Dissection (3160); Unspecified Nervous System Problem (4426)
Event Date 06/15/2021
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 patient experienced carotid dissection, and minor transient acalculia. The patient was hospitalized form (b)(6) 2021 to (b)(6) 2021, and anti-platelet medication was administered. The angio-computerized tomography (ct)-1 on (b)(6) 2021 showed no complication. An mri on (b)(6) 2021 showed minor punctiform stroke. It was noted the rist catheter was unstable in the carotid artery dissection. The site related assessment determined the event was possibly related to the study procedure, but not related to the study devices. The event was resolved on (b)(6) 2021.

 
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Brand NameRIST 071 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
david gustafson
9775 toledo way
irvine, CA 92618
7635149628
MDR Report Key12330858
MDR Text Key266865153
Report Number2029214-2021-01021
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeFR
PMA/PMN NumberK211990
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 09/27/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/17/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number107F-079-105V01
Device Catalogue Number107F-079-105V01
Device LOT Number16742-01
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 Received09/17/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured02/16/2021
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: 08/17/2021 Patient Sequence Number: 1
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