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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
Catalog Number LAUNCHER(UNK)
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Death (1802)
Event Date 07/27/2016
Event Type  Death  
Manufacturer Narrative
Literature reference: doi: 10. 1002/ccd. 26773. If information is provided in the future, a supplemental report will be issued.
 
Event Description
In a study of 60 patients, 7f launcher guide catheters were used in complex transradial pci procedures. The primary endpoint was procedural success which was defined as completion of the planned procedure through the initially selected radial access route. There were two procedural failures: one case of unsuccessful cto-pci of the right coronary artery and one case requiring conversion to femoral access due to the presence of extreme subclavian tortuosities. There were three vascular access-site complications including two type ii hematomas and one uncomplicated guide catheter-induced brachial dissection. The occurrence of radial spasm was reported in seven patients. Doppler ultra-sound imaging of the radial artery at 1 month was available in 62 out of 64 radial access with three documented cases of radial artery occlusion. One patient was lost to follow-up and another patient died from cardiovascular cause after hospital discharge, but before 1-month follow-up.
 
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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 Key7662144
MDR Text Key113148929
Report Number1220452-2018-00084
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
K022764
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 07/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/04/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberLAUNCHER(UNK)
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 Received06/22/2018
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: 07/04/2018 Patient Sequence Number: 1
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