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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC LAUNCHER 6F GUIDE CATHETER CATHETER, PERCUTANEOUS

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MEDTRONIC, INC LAUNCHER 6F GUIDE CATHETER CATHETER, PERCUTANEOUS Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Muscle Spasm(s) (1966); Perforation (2001)
Event Date 12/04/2017
Event Type  Injury  
Manufacturer Narrative

Lit ref: doi. Org/10. 1016/j. Carrev. 2017. 12. 002. If information is provided in the future, a supplemental report will be issued.

 
Event Description

Launcher guide catheter devices were used in procedures as part of a study to evaluate the success rates of the balloon assisted tracking (bat) technique in overcoming anatomical difficulties during radial coronary interventional procedures. Overall in 30 (2. 72%) patients, anatomical difficulties were encountered along the ra course requiring use of bat to complete the procedure. Radial spasmwas the commonest problem accounting for 2/3 cases. Most patients underwent pci (86. 7%) and remaining had coronary angiography only. Two third of patients were treated for acute coronary syndrome (acs). In one case, bat was utilised twice during the same procedure due to anatomical problems both at the level of the radial and the subclavian arteries. In another case bat was utilised twice to advance two guide catheters for multivessel pci. Anatomical difficulties were effectively overcome in all cases (100%). Coronary procedure was successfully completed in all 30 cases without the need for obtaining alternative arterial access. Mean added duration time was 131 s. Radial artery perforation was encountered in 16. 6% of patients. There were no procedure related complications.

 
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Brand NameLAUNCHER 6F 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 Key8440297
MDR Text Key139453842
Report Number1220452-2019-00029
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeUK
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 03/21/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/21/2019
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 Received03/11/2019
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: 03/21/2019 Patient Sequence Number: 1
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