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	10/12/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to the manufacturing facility for evaluation.The catheter cable connector was visually inspected under magnification and all pins are straight.Damage in the coil was noted in the kinked region.Visual inspection under magnification revealed the fep was damaged and the coil was exposed.The catheter did not pass continuity and resistance functional testing: e+ to e- 69.5ohms (80ohms to 113ohms), tc+ to tc- 157.8 ohms (less than or equal to 250ohms), resistor 1 value 13.69kohms (13.43kohms to 13.97kohms), and resistor 2 value 8.06 kohms (7.90kohms to 8.22kohms).When the catheter was plugged into the two different rf generators it generated an advisory message of ¿advisory: impedance low.Replace device¿.
Event or Problem Description
Physician attempted to treat patient using a closurefast catheter.Catheter was inserted into the patient.It is reported that generator displayed an error message stating catheter was unable to be recognised.Upon removal of the catheter, one kink was noted to the heating coil.A second closurefast catheter was used to complete the procedure.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; 4600n nathan lane; plymouth MN 55442
• MDR Report Key: 6581609
• Report Number: 2183870-2017-00219
• Device Sequence Number: 133815
• Product Code: GEI
• UDI-Device Identifier: 10884521058057
• UDI-Public: 10884521058057
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K111887
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2017

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: 10/31/2017
• Device Catalogue Number: CF7-7-100
• Device Lot Number: 553098X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2017
• Initial Date Received by Manufacturer: 04/25/2017
• Supplement Date Received by Manufacturer: 04/25/2017
• Initial Report FDA Received Date: 05/22/2017
• 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