MAUDE Adverse Event Report: KENDALL USA SAN JOSE PLANT CLOSUREFAST CATHETER; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	CF7-7-100
Medical Device Problem Codes	Kinked (1339); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation summary: the closurefast catheter and an image was received for analysis.Image received from customer showed the fep on the coil was deformed and had a red material embedded the fep.There is also evidence of bubbling of the fep.The deformation to the fep is consistent with what can occur when uneven or lack of compression is applied during activation.The red material observed within the fep give the appearance of a burn, however the material discovered is likely blood.Visual inspection of the catheter shaft revealed a kink.The kink is approximately 99.8mm proximal from the distal tip.The coil was examined: a bend in the coil was observed.The bend was observed approximately 3.7mm proximal to the distal tip.Visual inspection of the coil under magnification reveal fep on the coil was deformed and had a red material embedded the fep.There is also evidence of bubbling of the fep, a slice/ cut of the fep was noted on the coil.The coil is observed to be exposed.The catheter did pass continuity and resistance functional testing.The catheter passed functional testing on rfg2 and rfg3 generator.The proper device was recognized by each 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 was using a closurefast catheter with an rfg2 generator for a radiofrequency ablation procedure of the great saphenous vein (gsv).The lumen was flushed before use and the ifu was followed.Procedure was carried out under general anesthesia with the use of tumescent infiltration and transducer compression.Correct temperature was reached.On completion of the procedure, one kink was observed on the coil of the catheter.All segments were treated and the vein closed.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): KENDALL USA SAN JOSE PLANT; 5799 fontanoso way; san jose CA 95138
• MDR Report Key: 6659315
• Report Number: 2953189-2017-05000
• Device Sequence Number: 72523
• Product Code: GEI
• UDI-Device Identifier: 10884521058057
• UDI-Public: 10884521058057
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 05/23/2017

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: 03/31/2018
• Device Catalogue Number: CF7-7-100
• Device Lot Number: 553361X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2017
• Initial Date Received by Manufacturer: 05/23/2017
• Supplement Date Received by Manufacturer: 05/23/2017
• Initial Report FDA Received Date: 06/21/2017
• 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
• Patient Age: 72 YR
• Patient Weight: 87