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

Model Number	CF7-7-60
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	04/03/2017
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
Physician was attempting to treat venous insufficiency in the great saphenous vein (gsv) using a closurefast radiofrequency ablation catheter.It was reported that the catheter was not responding/ not recognized by the generator.Test was performed with two other catheters and both did not work.Physician then performed saphenectomy, an open surgery.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: CLOSUREFAST CATHETER
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN
• MDR Report Key: 6542843
• Report Number: 2183870-2017-00195
• Device Sequence Number: 13640733
• Product Code: GEI
• UDI-Device Identifier: 10884521058071
• UDI-Public: 10884521058071
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K111887
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2017

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 Expiration Date: 03/31/2018
• Device Model Number: CF7-7-60
• Device Catalogue Number: CF7-7-60
• Device Lot Number: 553335X
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/04/2017
• Supplement Date Received by Manufacturer: 04/04/2017
• Initial Report FDA Received Date: 05/03/2017
• Supplement Report FDA Received Date: 10/03/2017
• 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
• Patient Age: 56 YR