MAUDE Adverse Event Report: COVIDIEN GOOSENECK SNARE; CATHETER, PERCUTANEOUS

Model Number	GN2500
Medical Device Problem Codes	Entrapment of Device (1212); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Device Embedded In Tissue or Plaque (3165); Embolism/Embolus (4438)
Date of Event	03/15/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Physician was attempting to use the gooseneck snare during procedure to treat little calcified lesion in the mid right interior vena cava (ivc).The vessel had little tortuosity and 0% stenosis.The device was inspected with no issues noted.The device was prepped per the ifu with no issues.It was reported that the marker band on snare came off during non-medtronic ivc filter removal and embolized to patient's lung.Filter had been implanted in the patient for several years.The marker band or ring detached from the gooseneck snare or delivery catheter not the filter.The marker band was not retrieved.It had embolized to the lung.No adverse events were reported.Patient was discharged and doing well.No further patient injury reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
No resistance was felt when advancing the goose neck snare.Marker band dislodgment occurred during removal of the filter.No attempt was made to retrieve the dislodged marker band.Procedure was completed with the first snare.No plans to remove the marker band as physician feels the risk outweighs the benefits.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.
Additional Manufacturer Narrative
Image analysis two images were provided for evaluation.In the images you can see what appears to be part on the device left in the vessel.Product analysis visual inspection device returned loaded in a micro catheter.No torque device or micro introducer was returned no damage to micro snare loop dry biologics observed on the snare loop damage was observed to the tip of the micro catheter tip and the markerband was missing.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.

• Brand Name: GOOSENECK SNARE
• Common Device Name: CATHETER, 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: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 13962499
• Report Number: 2183870-2022-00108
• Device Sequence Number: 4163999
• Product Code: DQY
• UDI-Device Identifier: 00763000225285
• UDI-Public: 00763000225285
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K970668
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/18/2022

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 Model Number: GN2500
• Device Catalogue Number: GN2500
• Device Lot Number: B342905
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2022
• Supplement Date Received by Manufacturer: 03/31/2022; 08/17/2022
• Initial Report FDA Received Date: 03/31/2022
• Supplement Report FDA Received Date: 04/04/2022; 08/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/23/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Weight: 59 KG