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

Model Number	CF7-7-60
Medical Device Problem Code	Delamination (2904)
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
Evaluation summary: the closurefast catheters was returned for analysis.No cine images or procedure notes were returned for evaluation.The catheter was examined: visual inspection of the catheter shaft revealed no abnormalities or deformities.The heating element /coil was observed to have damage.A burnt/char marked in the coil was observed.Visual inspection under magnification revealed the fep was damaged.Red dried material was observed within the fep.The coil is exposed.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.
Event or Problem Description
The physician used a closurefast catheter for radiofrequency ablation procedure.It was reported the physician ablated one side of the leg, the catheter was removed from the patient; attempts were made to flush the catheter before reinsertion but found to be occluded.Another catheter was used to treat the patient without any issues noted.No patient injury 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: 6600177
• Report Number: 2183870-2017-00226
• Device Sequence Number: 369351
• Product Code: GEI
• UDI-Device Identifier: 10884521058071
• UDI-Public: 10884521058071
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 05/01/2017

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: 12/31/2017
• Device Model Number: CF7-7-60
• Device Lot Number: 553208X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2017
• Initial Report FDA Received Date: 05/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1