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

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

Patient Problems Inflammation (1932); Reaction (2414); Patient Problem/Medical Problem (2688)

Event Date 02/08/2019

Event Type  Injury  

Manufacturer Narrative

Event date - month and year valid.If information is provided in the future, a supplemental report will be issued.

Event Description

The patient was treated venaseal.It was reported by the patient that wounds developed on their leg that are not healing.An ultrasound showed glue under the skin.The two sores were debrided by the treating physician but they are not healing.

Manufacturer Narrative

Additional information: patient¿s short saphenous vein (ssv) on left leg was treated.Procedure was uneventful.No deviations occurred during the procedure.The catheter tip was 5cm caudal to the sapheno femoral junction (sfj) and there was compression of the ssv as the catheter was withdrawn.Patient attended follow-up 4 days post procedure and was seen to have closure without any issues.Approximately 8 weeks post procedure the patient attended an appointment where an induration was observed around the entry site of the needle.It was reported to be approximately 1-2cm in diameter.The physician saw the patient 3 days later and probed the point with an 18-gauge needle to about 2cm finding no evidence of any foreign body reaction or tissue induration.No foreign body reaction was observed on ultrasonography.Patient was seen again 2 weeks later, and the area of induration was less but an area of firmness was still present.The patient returned approximately a week later and there was some indication of inflammation, so the patient was prescribed keflex.2 weeks post this appointment the patient returned to another follow-up appointment and it was reported that it appeared as if something was extruding from the skin and felt it was a foreign body and was hard and firm to the touch.The patient returned the next day and the reaction had gone from what was seen the previous day and was less than 1cm circumferentially.The patient is reported to be doing well and improving.It is believed this may be a delayed reaction to foreign body.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VENA SEAL CLOSURE SYSTEM
• Type of Device: AGENT, OCCLUDING, VASCULAR, PERMANENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 8444113
• MDR Text Key: 139570652
• Report Number: 9612164-2019-01006
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/25/2019
• 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
• Patient Age: 65 YR