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	01/12/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: the closurefast catheter was returned for evaluation.Visual inspection of the catheter shaft revealed multiple kinks.The kinks are approximately 39.5 mm and 84.4 mm proximal from the distal tip.The catheter cable connector was visually inspected under magnification and no damage was observed to connector pins.A damage in the coil was noted.Visual inspection under magnification revealed the fep was damaged and the coil was exposed.There is evidence of a dent in the damage region of the coil.Bubbling sanguine material was also observed in the damage region of the coil.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 treat patient at the great saphenous vein using a closurefast catheter with a rfg2 generator.Transducer compression and tumescent infiltration were used.Ifu was followed.It is reported that catheter was unable to reach correct temperature and wattage during the procedure.When physician removed the catheter from the patient, they noted 1-2 kinks on the outer shaft of the device.A second catheter was used to complete the procedure.No patient injury reported.When device returned to the evaluation facility, it was noted that the fep was deformed.
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; 4600n nathan lane; plymouth MN 55442
• MDR Report Key: 6546899
• Report Number: 2183870-2017-00199
• Device Sequence Number: 16396460
• Product Code: GEI
• UDI-Device Identifier: 10884521058057
• UDI-Public: 10884521058057
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2017

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: 11/30/2017
• Device Catalogue Number: CF7-7-100
• Device Lot Number: 553119X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2017
• Initial Date Received by Manufacturer: 04/07/2017
• Supplement Date Received by Manufacturer: 04/07/2017
• Initial Report FDA Received Date: 05/05/2017
• Supplement Report FDA Received Date: 10/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 39 YR
• Patient Weight: 110