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

Catalog Number	CF7-7-60
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation summary: visual inspection of the catheter shaft revealed no abnormalities or deformities.Visual inspections of the connector pins showed they are straight.A damage in the coil was noted.Visual inspection under microscope shows no damage to the fep and the coil is not exposed.The catheter passed 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.However, it should be noted that a damage/scar mark on the coil was observed.The appearance of the damage/scar mark on the coil is due to uneven compression of the vein over the full length of the heating element, thus resulting in inconsistent effectiveness and/or possible catheter damage.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
A closurefast catheter was used for a radiofrequency ablation procedure.The lesion site was 40cm.It was reported that during use, messages ¿treatment halted non-uniform temperature "and ¿14 seconds within target temperature ranges ¿ appeared before reaching 20 second.The unit started to work properly later and it performed ablation a few times as usual but another product was used just in case.No patient harm 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: 6593222
• Report Number: 2183870-2017-00223
• Device Sequence Number: 10819395
• 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): 04/26/2017

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: CF7-7-60
• Device Lot Number: 553202X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2017
• Initial Report FDA Received Date: 05/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1