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

Catalog Number VS-402

Device Problem Defective Device (2588)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 08/24/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the physician was attempting to use a venaseal device as per the ifu.The lumen was flushed prior to use.5ml of adhesive was loaded into the venaseal syringe and delivery catheter.It was reported that there was a kink in the catheter during insertion into the patient preventing the catheter advancing through the venaseal sheath.The physician reported that the venaseal sheath was placed, the delivery catheter was filled with glue and inserted into the blue sheath, the catheter would not advance through the sheath, catheter and sheath was removed.The procedure was successfully completed using endovenous laser treatment thermal(evlt) ablation.No patient injury was reported.

• Brand Name: VENA SEAL CLOSURE SYSTEM
• Type of Device: AGENT, OCCLUDING, VASCULAR, PERMANENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; parkmore; galway,gw
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; parkmore; galway,gw
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 7901291
• MDR Text Key: 121437800
• Report Number: 9612164-2018-02489
• 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
• Report Date: 09/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2018
• Is this an Adverse Event Report?: Yes
• 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
• Date Manufacturer Received: 08/27/2018
• 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