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

Catalog Number VS-402

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/07/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The physician used venaseal to treat a patient¿s great saphaneous vein (gsv).The ifu was followed and a guidewire was used for the procedure.It was reported that the sfj failed to close at the junction after the initial two aliquots were administered and three minute hold was performed.The vein measured 1.6cm and appeared to be patent at the junction.The physician believed that the adhesive used in the initial treatment became balled up and stuck to the catheter tip contributing to the incomplete closure of the vein.A piece of adhesive appeared to be attached to the wall of the vein distal to the junction although it was not moving there is some concern that it may dislodge.Subsequent treatments in eight segments closed the remainder of the vein.The procedure was completed and no additional treatment was required.No patient injury reported.

Manufacturer Narrative

The patient has since returned for a follow-up appointment 4 days later and it was determined that the vein was closed up to the sfj and the patient is doing well.Patient will continue to be monitored.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: 8416006
• MDR Text Key: 138659911
• Report Number: 9612164-2019-00860
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: VS-402
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2019
• Initial Date FDA Received: 03/13/2019
• Supplement Dates Manufacturer Received: 03/13/2019
• Supplement Dates FDA Received: 04/01/2019
• 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