MAUDE Adverse Event Report: COVIDIEN GENERATOR RADIOFREQUENCY; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	RFG3
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	Thrombus (2101)
Date of Event	08/09/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
It is reported that out of 55 radio-frequency ablation cases of the great saphenous vein (gsv), physician has observed 7 cases of endothermal heat induced thrombosis (ehit) - class 1.All 7 procedures were completed using this generator and cf7-7-60 closurefast catheters.No individual patient information available as these incidents were not reported as they happened but provided in the form of a statement made by the physician.These procedures were carried out within the last 3 months.No catheter lot numbers available.All patients who were observed to have ehit were treated with lovenox (anticoagulant medication) and/or xyralto (anticoagulant medication).All patients are reported to be fine.
Additional Manufacturer Narrative
Manufacturer provided the unit history report for this device.A review of the unit history report from the manufacturer showed the generator was able to pass all testing prior to initial release.Unit functionally performed as expected however, the plastic portion of the catheter port was peeling off inside and the power switch needed to be re-aligned.During rf treatment, the closurerfg radiofrequency generator monitors the catheter¿s parameters (temperature, impedance, and rf power).Should one of these measurements be too high or too low, the closurerfg generator may stop rf treatment, sound an alarm, and/or display an alarm message.The therapy output data was overwritten by the service technician at the manufacturers site before it could be extracted for analysis.This has prevented analysis of the output data to determine if there were any unusual therapy behaviours contributing to these observations.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Updated information received 23-jan-2018 correction to number of patients involved from 7 to 10 patients who developed ehit.Event date of this event: (b)(6) 2017 new info - patient demographics and procedural info provided: sex; male bmi: 23 patient had treatment of left leg with the catheter- sfj distance of 3.0cm.The diameter pre rfa was 7.7mm sfj, 14.5 prox thigh <(>&<)> 14mm mid thigh.A total of 42cm was treated.Patient developed ehit - described by the physician as 'loosely attached in gsv not extending'.If information is provided in the future, a supplemental report will be issued.

• Brand Name: GENERATOR RADIOFREQUENCY
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 6850965
• Report Number: 2183870-2017-00384
• Device Sequence Number: 648599
• Product Code: GEI
• UDI-Device Identifier: 10884521196544
• UDI-Public: 10884521196544
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K141858
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/21/2018

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 Catalogue Number: RFG3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2017
• Initial Date Received by Manufacturer: 08/09/2017
• Supplement Date Received by Manufacturer: 12/14/2017; 01/23/2018
• Initial Report FDA Received Date: 09/08/2017
• Supplement Report FDA Received Date: 01/12/2018; 02/21/2018
• 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