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

Model Number	GN1000
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Device Embedded In Tissue or Plaque (3165); Insufficient Information (4580)
Date of Event	02/17/2022
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
Physician was attempting to use the gooseneck snare during procedure.The device was inspected with no issues noted.The device was prepped per the ifu with no issues identified.It was reported that part of the product fell off and is embedded in the pulmonary artery.The device fragment remains in patient the tip part of snare seemed to have been cut off without any resistance.Patient status is alive with injury.Patient has been discharged without life-threatening effect, but surgery is needed to remove the device fragment left in the patient's body.
Additional Manufacturer Narrative
Product analysis visual inspection: only the micro catheter was returned for evaluation.Device covered in biologics damage to tip of micro catheter.Kink observed on micro catheter.No detachment was observed to the micro catheter.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.
Additional Manufacturer Narrative
Additional information: the opinion of the customer is that the tip of the snare is not cut off, but only the marker on the catheter appears to have fallen off.The wire or loop did not fall off the snare reentry.Image review: one image was provided for evaluation.It is not clear from the video if any detachment occurred.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: 13584287
• Report Number: 2183870-2022-00061
• Device Sequence Number: 20266563
• Product Code: DQY
• UDI-Device Identifier: 00763000225247
• UDI-Public: 00763000225247
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/25/2022

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 Expiration Date: 08/02/2026
• Device Model Number: GN1000
• Device Catalogue Number: GN1000
• Device Lot Number: B244036
• 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: 02/17/2022
• Supplement Date Received by Manufacturer: 05/16/2022; 07/06/2022
• Initial Report FDA Received Date: 02/23/2022
• Supplement Report FDA Received Date: 05/17/2022; 07/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/03/2021
• 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: Required Intervention
• Patient Sex: Unknown