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

Catalog Number	CF7-7-100
Medical Device Problem Codes	Kinked (1339); Defective Device (2588)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Image received from customer show a bend/kink in the heating element/coil.There is evidence of fep shrink/ melt in the coil.
Event or Problem Description
The physician was attempting to use a closurefast catheter to treat a venous insufficiency in the gsv.The device was prepped as per the ifu with no issues identified.The physician attempted to treat a segment proximal to the sfj and an error message appeared on the generator.The coil portion of the catheter kinked.The physician used another catheter to complete the procedure.No patient injury was reported.
Additional Manufacturer Narrative
Describe event problem: confirmation has been received that the coil was melted; there was no vessel damage; the error message appeared on the generator after three cycles; the vessel diameter was 7mm and was not tortuous or calcified; two segments of the vessel were treated; in the first segment the physician performed two cycles; the physician didn¿t change the generator parameters and there was resistance removing the catheter.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Product analysis: the closurefast catheter was returned for analysis no ancillary devices or procedure notes were returned.Visual inspection of the catheter revealed kinking and a melted fep on the catheter coil area.There were no issues noted on the distal front half of the coil area of the catheter.During microscopic observation of the kinking on the coil shaft, an unknown residue and coil/fep melt causing coil damage was observed.The coil did not appear to have been exposed.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; 9775 toledo way; irvine CA 92618
• MDR Report Key: 7137517
• Report Number: 2183870-2017-00607
• Device Sequence Number: 903062
• Product Code: GEI
• UDI-Device Identifier: 10884521058057
• UDI-Public: 10884521058057
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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,Followup
• Report Date (Section B): 03/09/2018

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2018
• Initial Date Received by Manufacturer: 12/01/2017
• Supplement Date Received by Manufacturer: 12/01/2017; 02/09/2018
• Initial Report FDA Received Date: 12/21/2017
• Supplement Report FDA Received Date: 02/08/2018; 03/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1