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	Patient Problem/Medical Problem (2688)
Date of Event	05/02/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Evaluation summary: the closurefast catheter was returned for evaluation.Visual inspection of the catheter shaft revealed a kink.The kink was observed approximately 24.2mm proximal from the distal tip.The catheter connector was examined under magnification revealed all pins are straight.The catheter did pass continuity and resistance functional testing: e+ to e- 87.1ohms, tc+ to tc- 111.6ohms, resistor 1 value 13.70kohms, and resistor 2 value 8.06kohms.The catheter passed functional testing on rfg2 generator.The proper device was recognized by rfg generator when plugged in, the expected low temperature advisory was displayed when activated.When the temperature rose to 120c, device completed cycle without any advisory message being seen.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Physician attempted to use a closurefast catheter for a radiofrequency ablation procedure.Catheter defect occurred during treatment.Customer cannot remember if there were any error codes/messages/warnings from the generator.It was reported that there was no output from the catheter so ablation could not be performed.No patient injury reported.Procedure was converted to vein stripping.

• 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: 6603764
• Report Number: 2183870-2017-00229
• Device Sequence Number: 1089168
• 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): 05/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2018
• Device Catalogue Number: CF7-7-60
• Device Lot Number: 553466X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2017
• Initial Report FDA Received Date: 05/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention