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

MAUDE Adverse Event Report: COVIDIEN MICROSNARE 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
 

COVIDIEN MICROSNARE CATHETER, PERCUTANEOUS Back to Search Results
Device Problem No Apparent Adverse Event (3189)
Patient Problems Pulmonary Embolism (1498); Embolism (1829); Myocardial Infarction (1969); Patient Problem/Medical Problem (2688)
Event Type  Injury  
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Event Description

Medtronic conducted a post market clinical follow-up (pmcf) survey to seek out potential new risks and assess performance of the amplatz goose neck snare kit and the amplatz goose neck microsnare kit. Survey results from an interventional cardiologist in practice 14 years: physician has been using medtronic¿s amplatz goose neck snare kit and amplatz microsnare kit since 2017, using a total of 100 amplatz goose neck snare kits and 50 amplatz goose neck microsnare kits in the last year. Of the amplatz goose neck microsnare kits used, 10 were used during peripheral vascular procedures, and 40 were used during coronary vascular procedures. During use of the amplatz goose neck snare kit in the arterial vasculature embolization during peripheral cases is reported to have occurred in 5 patients, and myocardial infarction in anterior wall (5 patients). During use of the amplatz goose neck snare kit in the venous vasculature, a pulmonary embolism event was reported for 1 patient. During use of the amplatz goose neck snare kit, there is one event reported with stripping fibrin sheath from an indwelling catheter resulting in catheter damage on small-bore catheter. Other complications encountered during use of the amplatz goose neck snare kit are reported as infection in 1 patient. During use of the amplatz goose neck microsnare kit in the arterial vasculature, embolization during peripheral cases is reported to have occurred in 1 patient, and myocardial infarction in 1 patient. During use of the amplatz goose neck microsnare kit in the venous vasculature, a pulmonary embolism event was reported for 1 patient. During use of the amplatz goose neck microsnare kit in coronary vasculature an embolization event and a stroke event are reported for 1 patient each other complications encountered during use of the amplatz goose neck microsnare kit are reported as vessel damage reported as "boral" renal function in 1 patient of the above complications (adverse events), some of these are listed as having been reported to medtronic previously. Due to limited information these are included in reporting.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMICROSNARE
Type of DeviceCATHETER, PERCUTANEOUS
Manufacturer (Section D)
COVIDIEN
4600 nathan lane north
plymouth MN 55442
Manufacturer (Section G)
COVIDIEN
4600 nathan lane north
plymouth MN 55442
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
091708734
MDR Report Key8626884
MDR Text Key145614060
Report Number2183870-2019-00279
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeUK
PMA/PMN NumberK925439
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 05/21/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/21/2019
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 Received05/08/2019
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

-
-