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	11/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The closurefast catheter was returned inside a shelf label carton.No ancillary devices, cines images or procedural notes were received for evaluation.The device was visually examined.It was observed, under microscope, that damage and an unknown burnt residue were present on the catheter coil area.The coil was also kinked in multiple places and the fep was torn and pulled off the coil area.An unknown plastic could be seen melted to the coil and the coil was exposed as a result of the torn <(>&<)> burnt fep.
Event or Problem Description
It was reported that the physician used a closurefast to treat 4 segments of the anterior lateral accessory vein.The ifu was followed and the device was not reprocessed.The physician then intended to use the same device to treat the great saphenous vein(gsv).Before proceeding to the gsv, the physician noticed that the thermocouple had melted.A new catheter was opened and the physician proceeded to successfully treat the gsv with this new catheter.No patient injury was reported.

• 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: 7167067
• Report Number: 2183870-2018-00007
• Device Sequence Number: 1918095
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 01/05/2018

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: 06/30/2018
• Device Catalogue Number: CF7-7-100
• Device Lot Number: 553439X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2018
• Initial Report FDA Received Date: 01/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 49 YR