MAUDE Adverse Event Report: COVIDIEN CLOSUREFAST 6FR CATHETER; ELECTROSURGICAL, CUTTING & COAGULATION & ACCES

Catalog Number	CF6-8-100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	10/31/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Physician used a closurefast catheter during treatment of the patients left proximal great saphenous vein (gsv).Post op, ehit kabnick class 2 propagation into the common femoral vein (cfv) and occupation of a cross-sectional area of less than 50% was found in the sapheno-femoral junction (sfj).The onset of symptoms was directly after procedure (within same day).The patient was prescribed eloquis 5mg twice daily for 28 days.There are no known patient allergies.There are no known co-morbidities.Issue is still present.
Additional Manufacturer Narrative
Film image analysis one image was reviewed showing a picture of two ultrasound images side by side.The image on the left shows an occluded vessel with intravascular substance, which given the history is thrombus and not glue, extending into anther vessel, almost 50% into the vessel.This appears to be the occluded gsv with extension of thrombus into the common femoral vein.The extension appears to be slightly 50% of the lumen of the cfv.The image on the right shows color flow doppler over the same area.There appears to be some color flow in the cfv but not in the gsv, as expected.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: CLOSUREFAST 6FR CATHETER
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCES
• 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: 20784062
• Report Number: 2183870-2024-00434
• Device Sequence Number: 12029188
• Product Code: GEI
• UDI-Device Identifier: 00763000552176
• UDI-Public: 00763000552176
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K111887
• 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
• Report Date (Section B): 01/31/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2025
• Device Catalogue Number: CF6-8-100
• Device Lot Number: 232610039
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2024
• Supplement Date Received by Manufacturer: 01/28/2025
• Initial Report FDA Received Date: 11/26/2024
• Supplement Report FDA Received Date: 01/31/2025
• Date Device Manufactured: 09/18/2023
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 83 KG