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

Model Number CF7-7-100

Device Problem Biocompatibility (2886)

Patient Problems Burn(s) (1757); Inflammation (1932); Pain (1994)

Event Date 11/25/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

During index procedure, patient used closurefast ablation device to treat 7 segments in the great saphenous vein (gsv).The lumen was flushed prior to use.It is unknown if ifu was followed.No guidewire was used for the insertion of the catheter.Proper temperature was reached.It was reported that patient complained of pain during active treatment of one segment.Four days post procedure, skin irritation or burn was present at the knee joint.Only during one segment the patient complained about pain and 4 days after he had a skin burn exactly along that segment.The irritation or burn was treated with anti-inflammatory cream but the irritation/burn was still present.The procedure was completed according to ifu.No damage was seen at the coil heating element.No compression was used when heat applied to that one segment.No adjustments were made to the generator.No error messages occurred on the rfg3.No images were made available at this point.The physician has described the event as a serious case with a severe burn.The physician has done wound debridement and is seeing the patient regularly.No further patient injury reported.

Manufacturer Narrative

Image review: one image file was returned for review.Review of the image revealed a skin irritation/burn in close proximity to the patients knee joint consistent with the reported event.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.

• Brand Name: CLOSUREFAST CATHETER
• Type of Device: 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: 13359051
• MDR Text Key: 287276811
• Report Number: 2183870-2022-00032
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00643169862982
• UDI-Public: 00643169862982
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K111887
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: CF7-7-100
• Device Catalogue Number: CF7-7-100
• Device Lot Number: 212140295
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2022
• Date Device Manufactured: 08/02/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male