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

Catalog Number	CF7-7-60
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The closurefast catheter was returned for analysis.No ancillary devices, cine images or procedure notes were returned for evaluation.Visual inspection of the catheter revealed no abnormalities or deformities but the coil/heating element of the catheter was observed to be damaged approximately 1mm proximal from the distal tip.Visual inspection of the damaged coil under magnification revealed fep melt.There was evidence of stretching of the coil windings and the coil was exposed.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician was attempting to use a closurefast catheter to carry out an ablation procedure of an unknown vessel.After 3 ablations it was indicated that the temperature was raised and impedance dropped, however, when checked on echo, the site was not ablated at all.There was no burn mark confirmed by echo.Another catheter was used to complete the case.No patient harm was reported.

• Brand Name: CLOSUREFAST CATHETER
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN; 4600n nathan lane; plymouth MN 55442
• MDR Report Key: 7361059
• Report Number: 2183870-2018-00173
• Device Sequence Number: 16452155
• Product Code: GEI
• UDI-Device Identifier: 10884521058071
• UDI-Public: 10884521058071
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 03/22/2018

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: 02/28/2019
• Device Catalogue Number: CF7-7-60
• Device Lot Number: 553681X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2018
• Initial Report FDA Received Date: 03/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1