MAUDE Adverse Event Report: COVIDIEN VENA SEAL CLOSURE SYSTEM; AGENT, OCCLUDING, VASCULAR, PERMANENT

Model Number SP-101

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

Patient Problems Thrombus (2101); Foreign Body In Patient (2687)

Event Date 03/20/2017

Event Type  Injury  

Manufacturer Narrative

An ultrasound image was provided by the reporter and analyzed.Per analysis, the extension seemed to be most likely a glue/thrombus combination.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 Description

Physician used a venaseal closure system device to treat the great saphenous vein (gsv).It was reported that the catheter tip was 5cm caudal to saphenofemoral junction (sfj), and compression of the gsv was performed as per ifu.Approximately 2 months post-procedure, the patient had an ultrasound check; it was reported ¿a stopper between crossing point and the deep vein system¿ was observed.Physician was unable to confirm whether it was a thrombosis or a residue from the adhesive.The patient was treated, however there is no information available about the treatment given.Patient¿s status is unknown.

• Brand Name: VENA SEAL CLOSURE SYSTEM
• Type of Device: AGENT, OCCLUDING, VASCULAR, PERMANENT
• Manufacturer (Section D): COVIDIEN; 951 aviation pkwy ste 900; morrisville NC 27560
• Manufacturer (Section G): COVIDIEN; 951 aviation pkwy ste 900; morrisville NC 27560
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 6502469
• MDR Text Key: 73092771
• Report Number: 3011410703-2017-00114
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P140018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SP-101
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/20/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention