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

Model Number CF7-7-60

Device Problems Overheating of Device (1437); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/30/2019

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Physician used a closurefast catheter during patient treatment.Ifu was followed.A guidewire was used for insertion of the catheter.Proper temperature was reached.It is reported that after the procedure was done, a weird sound was heard so the physician pulled back the catheter and the heating coil was observed to be black when he pulled back the catheter on the last segment.The heating element or coil did not detach from the catheter.A part of the heating coil was reported to be peeled off in a shape like a scar.A little portion of the coil was exposed.There was no error message, code, or warnings displayed.A new catheter was opened to complete treatment.No patient injury reported.

Manufacturer Narrative

Product analysis: the closurefast catheter was for analysis.The closurefast catheter was inspected and noted the lot # on the power cord was 183550113.The coiled segment was inspected and found deformation of the fep at 4 cm from the distal tip and 5.5 cm from the distal tip.The proximal fep deformation showed black/charred debris within the fep.Dried/burned blood was observed within the fep material which appeared melted.The area of the melted fep shows the coil bent.No other damages or anomalies were noted.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.

• Brand Name: CLOSUREFAST CATHETER
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 9568723
• MDR Text Key: 195733405
• Report Number: 2183870-2020-00012
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00643169862968
• UDI-Public: 00643169862968
• Combination Product (y/n): N
• PMA/PMN Number: K111887
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2020
• Device Model Number: CF7-7-60
• Device Catalogue Number: CF7-7-60
• Device Lot Number: 183550113
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2020
• Date Manufacturer Received: 02/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1