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	10/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: visual inspection of the closurefast catheter revealed a kink to the shaft.The kink was approximately 80.8cm proximal from the distal tip.No damaged pins were observed.The coil/heating element was observed to be kinked.Visual inspection of the kinked coil/heating element under magnification revealed fep damage and a slice in the coil leading to exposure of the coil.There was evidence of dried blood in the coil, indicating that the device may have been used in the patient and the damage may have occurred during uneven compression of the vein.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician intended to use the closurefast catheter with a rfg2 generator as per ifu.No damage noted to packaging prior to use.It was reported the catheter could not be connected to the rfg2 due to pin damage.It was reported that the pins were bent and they did not remain on the connector and some remained in the receptacle.It was also reported that the heating coil was bent.Another device was used with the same rfg2 for the procedure.No allegation against the rfg2.

• 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: 8247604
• Report Number: 2183870-2019-00019
• Device Sequence Number: 11122692
• Product Code: GEI
• UDI-Device Identifier: 10884521058071
• UDI-Public: 10884521058071
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 01/15/2019

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: 07/30/2019
• Device Catalogue Number: CF7-7-60
• Device Lot Number: 172190029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2018
• Initial Report FDA Received Date: 01/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1