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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC LAUNCHER UNK GUIDE CATHETER CATHETER, PERCUTANEOUS

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MEDTRONIC, INC LAUNCHER UNK GUIDE CATHETER CATHETER, PERCUTANEOUS Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hematoma (1884); Muscle Spasm(s) (1966); Occlusion (1984); Vascular Dissection (3160)
Event Date 06/13/2018
Event Type  Injury  
Manufacturer Narrative

Lit ref: doi: 10. 1159/000488852. If information is provided in the future, a supplemental report will be issued.

 
Event Description

This study aimed to demonstrate that the combination of a local vasodilator (verapamil), modern materials, patent hemostasis, and intravenous anticoagulant only in the case of percutaneous coronary intervention, as compared to default heparin administration after sheath insertion, may optimize a combined endpoint, including radial artery occlusion (rao), radial artery spasm (ras), and access site complication. Medtronic launcher guiding catheters were amongst the devices used during the procedures. There was one death during the procedure, and two in follow-up. Primary endpoints included rao, radial artery occlusion; ras, radial artery spasm; asc; access site hemorrhagic complication. Secondary endpoints included radial artery dissection, rao, ras and asc.

 
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Brand NameLAUNCHER UNK GUIDE CATHETER
Type of DeviceCATHETER, PERCUTANEOUS
Manufacturer (Section D)
MEDTRONIC, INC
37a cherry hill dr
danvers MA 01923
Manufacturer (Section G)
MEDTRONIC, INC
37a cherry hill dr
danvers MA 01923
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
091708734
MDR Report Key8622776
MDR Text Key145478404
Report Number1220452-2019-00061
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeIT
PMA/PMN NumberK132673
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 05/20/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/20/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
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 Received05/14/2019
Was Device Evaluated By Manufacturer? No Answer Provided
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: 05/20/2019 Patient Sequence Number: 1
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