MAUDE Adverse Event Report: COVIDIEN CLOSUREFAST CATHETER; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number CF7-7-60

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Phlebitis (2004); Sepsis (2067); Thrombosis (2100)

Event Date 09/20/2020

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Physician used a closurefast ablation device during procedure.Tumescent infiltration was utilized.Physician reported that patient ended up with septic thrombophlebitis and needed surgery.No further patient injury reported.

Manufacturer Narrative

Additional information: the vessel treated was the right great saphenous vein.Calcification and degree of vessel stenosis is unknown.There was no damage or tampering noted to the outer or inner sterile packaging of the device.Ifu was followed.The lumen was flushed prior to use.The vessel presented severe tortuosity around the knee and a non-medtronic guidewire was used to advance the radiofrequency ablation catheter.There were no issues or deviations during the procedure and the vein is reported to have closed.Redness that looked like phlebitis was noted.Augmenting was administered initially then switched to vancomycin.Puss was coming out of the vein, quadruple in size, hot to tough and white cell count was up to 11, demonstrating infection.It is undetermined if the septic thrombophlebitis is related to the procedure with the closurefast catheter.The vein was surgically stripped from below the knee 11 days after the initial procedure.From the knee up to the junction the vein was not infected and it was closed, so the physician left part of the vein and only removed the infected section.On follow up patient did also have severe urinary tract infection (uti) and was treated with ancef.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.

Manufacturer Narrative

Additional information: the patient did not show up for a follow appointment and the physician has concluded that the patient is doing good.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: CLOSUREFAST CATHETER
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 10641205
• MDR Text Key: 210178318
• Report Number: 2183870-2020-00316
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00643169862968
• UDI-Public: 00643169862968
• Combination Product (y/n): N
• PMA/PMN Number: K111887
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 10/30/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Model Number: CF7-7-60
• Device Catalogue Number: CF7-7-60
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/25/2020
• Initial Date FDA Received: 10/07/2020
• Supplement Dates Manufacturer Received: 10/08/2020; 10/27/2020
• Supplement Dates FDA Received: 10/15/2020; 10/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 37 YR