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

Model 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	02/23/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation summary: the closurefast catheter and the ancillary device guidewire was returned stuck in the catheter.No cine images or procedure notes were returned for evaluation.Visual inspection of the catheter shaft revealed no abnormalities or deformities.A guidewire was stuck in the catheter luer hub section and was unable to be removed when attempts were made.The investigation was able to confirm coil damage to the catheter heating element/coil.A visual inspection of the device found the coil portion was bent and the fep was deformed approximately 4mm and extends to approximately 6.5mm from the distal tip.A visual inspection under magnification revealed the fep on the coil was deformed and had a red dried material embedded the fep was damage.The dark dried material discovered within the fep give the appearance of a burn, however the material discovered is likely dried blood.The appearance of the damage/char mark on the coil is due to uneven compression of the vein over the full length of the heating element.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
The physician intended to use a closurefast catheter to perform radiofrequency ablation procedure of the great saphenous vein.It was reported the closurefast was unable to reach temperature, the generator displayed error code ¿replace catheter¿.Another device was used to complete the procedure with the same generator no issues noted.No patient injury reported.
Additional Manufacturer Narrative
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: 6665642
• Report Number: 2183870-2017-00274
• Device Sequence Number: 1882068
• Product Code: GEI
• UDI-Device Identifier: 10884521058057
• UDI-Public: 10884521058057
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 05/26/2017

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: 08/31/2018
• Device Model Number: CF7-7-100
• Device Lot Number: 162630004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2017
• Initial Date Received by Manufacturer: 05/26/2017
• Supplement Date Received by Manufacturer: 05/26/2017
• Initial Report FDA Received Date: 06/23/2017
• Supplement Report FDA Received Date: 10/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1