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

Catalog Number	CF7-7-100
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 used a closurefast catheter for radiofrequency ablation procedure of the great saphenous vein (gsv) with the use of tumescent infiltration under local anesthesia.Device ifu was followed.It was reported that the procedure proceeded as normal and the vein closed as expected.After removing the catheter, the physician noted that the coil had unraveled slightly.It was confirmed by ultrasound that nothing was left in the patient.
Additional Manufacturer Narrative
Device evaluation summary: the closurefast device from a different lot number was received for analysis.The box received for analysis had the correct lot number, (553705x), but the product in the box was from a different lot, (553442x).The catheter, (lot 553442x) was examined: visual inspection of the catheter revealed no abnormalities or deformities.Visual inspection of the coil/heating element reveal no deformities.The returned catheter passed the continuity and resistance functional testing.It also passed the functional testing on rfg2 and rfg3 generators.The customer reported event of a coil damage was not confirmed.If information is provided in the future, a supplemental report will be issued.

• 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: 6749358
• Report Number: 2183870-2017-00318
• Device Sequence Number: 210829
• Product Code: GEI
• UDI-Device Identifier: 10884521058057
• UDI-Public: 10884521058057
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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,Followup
• Report Date (Section B): 07/31/2017

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: 02/28/2019
• Device Catalogue Number: CF7-7-100
• Device Lot Number: 553705X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2017
• Initial Date Received by Manufacturer: 06/28/2017
• Supplement Date Received by Manufacturer: 07/31/2017
• Initial Report FDA Received Date: 07/27/2017
• Supplement Report FDA Received Date: 08/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1