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

Model Number CF7-7-100

Device Problems Difficult to Remove (1528); Noise, Audible (3273)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/28/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Physician intended to use a closurefast catheter for patient treatment of the great saphenous vein (gsv).Tumescent infiltration was utilized and general anesthesia was used.Hand compression was used.Ifu was followed.It was reported that the physician used the catheter for treatment of the first segment, which reported to have worked for 20 seconds and reached the temperature of 120 well; however, a popping sound was heard near the heating coil.The physician tried to change the catheter but had difficulty removing the catheter.The physician did not want to use the catheter for more treatment after the 1 segment ablation and proceeded to do a stripping surgery.The physician was worried about the first segment that was treated with the device; however, it was reported to appear normal after stripping surgery.There was no patient injury reported.

Manufacturer Narrative

Additional information: excessive force was required for the removal of the device after unusual sound during 1st segment procedure.The bare coil of the catheter was not exposed and there were no burns or damage noted to the device or patient.No additional treatment was required besides the vein stripping.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

Product analysis: the closurefast device was returned to medtronic investigation lab for evaluation.The device was returned loosely within a double sealed biohazard bag.No ancillary devices or images from the procedure were received with the device.Two kinks were evident on returned device.No damage was noted to the catheter heating element/coil.Pin condition: no issues identified in the catheter connector.Visual inspection of the catheter shaft revealed 2 kinks, the first kink was observed approximately 30.5cm from the second kink was observed 64.5 from the distal tip.The catheter connector was plugged into the resistance tester to perform continuity and resistance functional test; the catheter was tested according to the test parameters, test methods and acceptance criteria.All 4 tests passed as per acceptance criteria.The catheter was connected and recognized by both the rfg3 and rfg2 lab generator when plugged in.When the temperature rose to 120 c, the device completed the cycle without an advisory message seen.During functional testing, the device successfully connected and completed 3 cycles with ¿popping sound¿ or no advisory error messages noted on either generator 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: 11278322
• MDR Text Key: 230233535
• Report Number: 2183870-2021-00052
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00643169862982
• UDI-Public: 00643169862982
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 05/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CF7-7-100
• Device Catalogue Number: CF7-7-100
• Device Lot Number: 190670248
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2021
• Date Manufacturer Received: 05/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention