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

Catalog Number	CF7-7-100
Medical Device Problem Codes	Kinked (1339); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/12/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation summary: the closurefast device was examined: the coil area was noted to be kinked at approximately 5.10 cm from the distal tip.The catheter cable connector was examined: all pins were visually inspected to be straight.The catheter connector plug showed slight visible markings on the plug area.It was observed under microscopic observation that part of the fep was torn and pulled off on the coil area where the kinking was observed.On further examination, it was noted that the coil was exposed due to the torn fep.The coil area appears to have damage to it and has an unknown residue covering the area.The catheter was not recognized by the rfg3 generator when plugged in, the expected low temperature advisory was not displayed when activated.When the cycle began on the rfg3 generator the advisory message ¿advisory: impedance low.Replace device¿.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 with a rfg3 for radiofrequency ablation treatment.It was reported that during powering on, the generator displayed the message "defective catheter".No moisture was found along the device and no splashing events occurred.A new catheter was used to complete the procedure with no issues reported.No patient injury 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: 7023155
• Report Number: 2183870-2017-00499
• Device Sequence Number: 13840232
• Product Code: GEI
• UDI-Device Identifier: 10884521058057
• UDI-Public: 10884521058057
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 11/10/2017

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: 12/29/2016
• Device Catalogue Number: CF7-7-100
• Device Lot Number: 162700005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2017
• Initial Report FDA Received Date: 11/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1