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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
Medical Device Problem Code Detachment of Device or Device Component (2907)
Health Effect - Clinical Code Device Embedded In Tissue or Plaque (3165)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
The physician intended to use an amplatz goose neck snare kit.It was reported that the metallic marker at the tip of the catheter dislodged during normal use, embolised and lodged in a very small branch of the r lung.The piece was very small and was difficult to retrieve and therefore was left in the patient.
 
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Brand Name
GOOSENECK SNARE
Common Device Name
CATHETER, PERCUTANEOUS
Manufacturer (Section D)
COVIDIEN
4600 nathan lane north
plymouth MN 55442
MDR Report Key8319685
Report Number2183870-2019-00064
Device Sequence Number13795752
Product Code DQY
UDI-Device Identifier00821684004036
UDI-Public00821684004036
Combination Product (Y/N)N
Initial Reporter StateNY
Initial Reporter CountryUS
PMA/510(K) Number
K970668
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 02/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date03/20/2023
Device Catalogue NumberGN1500
Device Lot NumberA616374
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/30/2019
Initial Report FDA Received Date02/08/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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