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

Catalog Number	CF7-7-100
Medical Device Problem Code	Kinked (1339)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	09/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluation summary: a kink was observed on the catheter shaft located approximately 85.00 cm from the distal tip.The catheter cable connector was examined, and all pins were straight.The catheter connector plug did not show any visible markings on the plug area.The catheter passed continuity and resistance functional testing.The functional testing on a rfg2 generator: the catheter was recognized by the rfg2 generator when plugged in and the expected low temperature advisory was displayed when activated.When the temperature rose to 120 c the device completed the cycle without any advisory message displayed.This was repeated for 5 cycles with no issues identified.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 7f 100 cm catheter with a rfg2 generator for the radiofrequency ablation treatment in two segments of the gsv and ssv in a tortuous vessel.The ifu was followed for device preparation and procedure.The lumen was flushed, and a guidewire/ insertion catheter was used.It was reported that during the procedure the catheter was not responding/recognized and the doctor could not advance the catheter after a couple of segments.Tumescent infiltration, iv sedation and local anaesthesia were used for the procedure.This catheter was not used to complete the procedure.The procedure was completed using perforation and foam sclerotherapy in the ssv.Post procedure, class ii compression stockings were used.No patient symptoms, complications or injury were reported.Catheter kink in use/ prep was also reported by the physician but no damage was noted to the packaging of the catheter.

• Brand Name: CLOSUREFAST CATHETER
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN; 4600n nathan lane; plymouth MN 55442
• MDR Report Key: 7041420
• Report Number: 2183870-2017-00511
• Device Sequence Number: 19068588
• Product Code: GEI
• UDI-Device Identifier: 10884521058057
• UDI-Public: 10884521058057
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 11/17/2017

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: 02/28/2018
• Device Catalogue Number: CF7-7-100
• Device Lot Number: 553352X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2017
• Initial Report FDA Received Date: 11/17/2017
• 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
• Patient Age: 46 YR
• Patient Weight: 72