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

Model Number CF7-7-60

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Thrombosis (2100); Injury (2348)

Event Date 10/14/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Physician used a closurefast catheter with an rfg3 during treatment of the patient's left great saphenous (gsv).Ifu was followed.Proper temperature was reached.No parameters of the rfg3 were changed.The vein is reported to have closed.7 days post procedure during follow-up, ehit was identified trailing into the common femoral vein (cfv).The patient was prescribed 81mg asa and will return for repeat duplex in 1 week.No further injury reported.

• Brand Name: CLOSUREFAST CATHETER
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; IE ; 091708734
• MDR Report Key: 10808833
• MDR Text Key: 215278939
• Report Number: 2183870-2020-00370
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00643169862968
• UDI-Public: 00643169862968
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111887
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: CF7-7-60
• Device Catalogue Number: CF7-7-60
• Device Lot Number: 200130151
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/23/2020
• Date Device Manufactured: 01/13/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Weight: 49