• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 Problems Hematoma (1884); Muscle Spasm(s) (1966); Occlusion (1984); Vascular Dissection (3160)
Event Date 07/27/2016
Event Type  Injury  
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. 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.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key7662165
MDR Text Key113156042
Report Number1220452-2018-00085
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeBE
PMA/PMN NumberK022764
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
0 PatientS WERE 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 HEALTH PROFESSIONAL
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

-
-