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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN GOOSENECK SNARE CATHETER, PERCUTANEOUS

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COVIDIEN GOOSENECK SNARE CATHETER, PERCUTANEOUS Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pulmonary Embolism (1498); Hemorrhage/Bleeding (1888)
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 13 years. Physician has been using medtronic¿s amplatz goose neck snare kit and amplatz microsnare kit since 2015, using a total of 9 amplatz goose neck snare kits and 5 amplatz goose neck microsnare kits in the last year. Of the amplatz goose neck microsnare kits used, 3 were used during peripheral vascular procedures, 1 used during a coronary vascular procedure, and 1 used during an extra-cranial neurovascular procedure. During use of the amplatz goose neck snare kit a stroke event was reported in 1 patient during use in the arterial vasculature reported as an ischemic stroke reversible after three months but fortunately without sequela. During use of the amplatz goose neck snare kit in the venous vasculature, a pulmonary embolism event was reported for 1 patient which required oxygen and anticoagulants for one month. During use of the amplatz goose neck snare kit, device entrapment during a slow and dangerous procedure (1 patient) and vessel damage described as a non-severe haemorrhage which spontaneously resolved without open surgery (1 patient) are other reported complications during use of the device. 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 which required definitive replacement. During use of the amplatz goose neck microsnare kit no complications were reported during use in the arterial vasculature or venous vasculature. During use of the amplatz goose neck microsnare kit in coronary vasculature a myocardial infarction (depending on placement) was reported for 1 patient. This was reported as being a severe heart attack that required intensive care for 7 days. During use of the amplatz goose neck microsnare kit in extra-cranial neurovasculature, a stroke event is reported for 1 patient which was described as mild and resolved without reliquaries in about a month no other complications are reported during use of the amplatz goose neck microsnare kit. 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 NameGOOSENECK SNARE
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 Key8620329
MDR Text Key145390750
Report Number2183870-2019-00272
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeIT
PMA/PMN NumberK970668
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 05/17/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/17/2019
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

Patient TREATMENT DATA
Date Received: 05/17/2019 Patient Sequence Number: 1
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