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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
Catalog Number GN1500
Device Problem Device Damaged by Another Device (2915)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 09/08/2017
Event Type  Injury  
Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.

 
Event Description

The physician was performing a procedure to retrieve an existing implantable pulse generator (ipg) from a patient and replace it with a new ipg device. It was reported that the existing ipg device was successfully snared using a gooseneck snare device, and while attempting to withdraw the gooseneck snare with the ipg, a pre-existing inferior vena cava (ivc) filter from an unknown manufacturer became ensnared and dislodged from the ivc. This led to a large mass containing an ipg device, gooseneck snare and the ivc filter that would not enter the micra sheath for removal from the patient. Vascular surgery was performed to retrieve the mass of devices by performing a venous cut down procedure. The three devices were successfully explanted and a new ipg was implanted. The patient is alive with no reported complications post-surgery.

 
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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 Key7066087
MDR Text Key93161905
Report Number2183870-2017-00530
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK970668
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 11/28/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/28/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberGN1500
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 Received10/30/2017
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

Patient TREATMENT DATA
Date Received: 11/28/2017 Patient Sequence Number: 1
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