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	05/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation summary: the closurefast catheter was received for evaluation.Visual inspection of the catheter shaft revealed no abnormalities or deformities.The heating element /coil was observed to be damaged.A visual inspection of the device found the coil heating element was bent and the fep was deformed approximately 4mm from the distal tip.A visual inspection under magnification revealed the fep on the coil had a red dried material embedded and the fep was damage.The red dried material discovered within the fep give the appearance of a burn, however the material discovered is likely dried blood.The coil was observed to be exposed.The investigation could confirm a fep damage to the catheter heating element/coil.
Event or Problem Description
Physician was using a closurefast catheter for radiofrequency ablation procedure of the great saphenous vein (gsv) using tumescent infiltration and compression (hand) under local anesthesia.The device was prepped as per ifu without issue and the lumen was flushed prior to use.Correct temperature was reached.It was reported that at the end of the procedure before final treatment there was a ¿catheter broken¿ message was displayed.Another catheter was used with the same generator without issue to complete the procedure.The vein was successfully 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: 6693753
• Report Number: 2183870-2017-00295
• Device Sequence Number: 13586080
• Product Code: GEI
• UDI-Device Identifier: 10884521058057
• UDI-Public: 10884521058057
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K111887
• 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
• Report Date (Section B): 06/09/2017

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: 05/31/2018
• Device Catalogue Number: CF7-7-100
• Device Lot Number: 553416X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2017
• Initial Report FDA Received Date: 07/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1