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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN MICROSNARE CATHETER, PERCUTANEOUS

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COVIDIEN MICROSNARE CATHETER, PERCUTANEOUS Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pulmonary Embolism (1498); Embolism (1829); 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 20 years. Physician has been using medtronic¿s amplatz goose neck snare kit and amplatz microsnare kit since 2016, using a total of 30 amplatz goose neck snare kits and 30 amplatz goose neck microsnare kits in the last year. Of the amplatz goose neck microsnare kits used, 5 were used during peripheral vascular procedures, 20 were used during coronary vascular procedures and 5 were used during extra-cranial neurovascular procedures during use of the amplatz goose neck snare kit in the arterial vasculature, an embolization event is reported for one patient, and a stroke event is reported for one patient. A pulmonary embolism event is reported for 1 patient during use of the amplatz goose neck snare kit in venous vasculature. During use of the amplatz goose neck microsnare kit in the arterial vasculature, an embolization event is reported for one patient, and a stroke event is reported for one patient. A pulmonary embolism event is reported for one patient during use of the amplatz goose neck microsnare kit in venous vasculature. 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.

 
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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 Key8627009
MDR Text Key145612252
Report Number2183870-2019-00283
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

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