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

Catalog Number	CF7-7-100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Patient Problem/Medical Problem (2688)
Date of Event	01/31/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the physician intended to use a closure fast catheter with an rfg3 generator to treat both the great saphenous vein (gsv) and the short saphenous vein (ssv).The ifu was followed.At the beginning of the procedure the generator displayed an error message that the temperature was too low to initiate treatment but after clicking on ok the treatment was carried out normally.During the procedure the gsv was successfully treated but during treatment of the ssv the patient felt pain and the device was stopped after 15 seconds in a segment below the calf.Access point was made in the malleolus.Hand compression was used and the vein was successfully closed.The patient was still reporting pain a day later.According to the physician, sural and saphenous nerves are damaged due to the procedure.He thinks that this may be temporary.
Additional Manufacturer Narrative
The physician believes that the nerve is damaged because he did more than one energy cycle in the lower part of the leg.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 55442
• MDR Report Key: 7305606
• Report Number: 2183870-2018-00120
• Device Sequence Number: 11029560
• Product Code: GEI
• UDI-Device Identifier: 10884521058057
• UDI-Public: 10884521058057
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2018

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: CF7-7-100
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/31/2018
• Supplement Date Received by Manufacturer: 07/17/2018
• Initial Report FDA Received Date: 03/01/2018
• Supplement Report FDA Received Date: 07/23/2018
• 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: Other
• Patient Weight: 75