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

Catalog Number	CF7-7-100
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The closurefast catheter was returned within its shelf carton and within its label pouch.No ancillary devices, cines, images or procedure notes were returned.Visual inspection of the catheter revealed damage to the coil/heating element.The fep could be seen to have melted.Multiple burnt areas in the coil was observed.The damage to the fep resulted in the coil being exposed.The catheter did pass continuity and resistance functional testing.In order to duplicate the customer reported event, the catheter was plugged into rfg2 and rfg3 generators.The catheter passed functional test.It should be noted that the damage observed on the heating element could be associated to uneven compression of the vein over the full length of the catheter thus resulting in the fep damage and the error message being seen on the generator during the procedure.
Event or Problem Description
Physician intended to use a closurefast catheter for treatment of great saphenous vein (gsv) under general anaesthesia using transducer compression.It is reported that after tumescent infiltration it was noted the catheter would not reach operational temperature.A new catheter was opened to complete the procedure.One segment was treated and the vein closed.No patient injury reported.

• 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: 7074820
• Report Number: 2183870-2017-00536
• Device Sequence Number: 939676
• Product Code: GEI
• UDI-Device Identifier: 10884521058057
• UDI-Public: 10884521058057
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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
• Report Date (Section B): 12/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: CF7-7-100
• Device Lot Number: 553704X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2017
• Initial Report FDA Received Date: 12/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1