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

Catalog Number CF7-7-60

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 03/22/2018

Event Type  Injury  

Manufacturer Narrative

The closurefast device was returned for analysis.No ancillary devices, cines images or procedural notes were received for evaluation.The closurefast device was examined and all pins were straight on the catheter cable connector.The catheter connector plug showed visible markings on the plug area.The catheter passed all of the continuity and resistance functional testing.The catheter passed functional testing on (b)(4) and (b)(4) generators and the correct device was recognized by the generators when plugged in.The expected low temperature advisory was displayed when activated.When the temperature rose to 120c, the device completed a cycle without any advisory message being seen.This was repeated for 5 cycles on each generator without issue.During each cycle time, the unit was subject to several additional tests such as movement in the power cable, pc board and strain relief.If information is provided in the future, a supplemental report will be issued.

Event Description

The physician was attempting to use a closurefast catheter to treat a venous insufficiency in the left gsv.It is reported treatment was proceeding as normal for the first couple of cycles but on the 3rd cycle, the generator displayed a warning sign that the catheter was broken and was to be removed.The message displayed was ¿device broken, needs to be replaced¿.A second closurefast catheter was opened but only able to be inserted to the mid-thigh.Treatment was resumed and completed through the access site at the proximal calf.5 segments were treated and the vein successfully closed.The physician was unable to pass the catheter past a portion of the mid thigh gsv with second catheter.The vessel was treated with sotradecol.

• Brand Name: CLOSUREFAST CATHETER
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN; 4600n nathan lane; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600n nathan lane; plymouth MN 55442
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 7463678
• MDR Text Key: 106587750
• Report Number: 2183870-2018-00244
• Device Sequence Number: 1
• Product Code: GEI
• 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: 04/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: CF7-7-60
• Device Lot Number: 172750017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/29/2018
• Initial Date FDA Received: 04/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/02/2017
• 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: 76 YR
• Patient Weight: 56