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

Catalog Number VS-402

Device Problems Difficult to Insert (1316); Infusion or Flow Problem (2964)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/07/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Physician used a venaseal kit for treatment of the patient¿s great saphenous vein (gsv).Ifu was followed during prep/procedure.A g uiderwire was used for insertion of the catheter.It is reported the physician was unable to pass the venaseal delivery catheter through blue venaseal sheath.It was decided to forego the blue sheath and access vessel directly with white venaseal delivery catheter which was successful.It was not possible to pass anything (wire, dilator, saline, flush) through blue sheath even on removal.Completed venaseal procedure in usual manner following ifu with approximately 8 segments treated only to note once white venaseal catheter was withdrawn that white catheter was not delivering adhesive appropriately.It is suspected the inability to deliver the white catheter through blue sheath initially caused the venaseal to come into contact with fluids resulting in glue polymerization thus not allowing delivery of adhesive from white catheter appropriately.Awaiting result of 2 day post procedural ultrasound.

Manufacturer Narrative

Product analysis: the venaseal kit was returned.Components returned are : a dispenser gun, a catheter, dilator and blue introducer.The blue introducer was examined.No abnormalities were noted on the catheter shaft.The blue introducer was unable to be flushed.The blue introducer was skived, and it was observed dried adhesive within the introducer sheath.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: the catheter tip was 5cm caudal to the sapheno femoral junction (sfj) prior to delivery of adhesive.Compression was used.Two-day ultrasound has confirmed the vein has closed and there is glue evident in the vein.No additional treatment required.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: patient noting improvement in symptoms.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: 8878216
• MDR Text Key: 153851750
• Report Number: 9612164-2019-03309
• 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,Followup,Followup
• Report Date: 10/29/2019

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 Expiration Date: 10/31/2020
• Device Catalogue Number: VS-402
• Device Lot Number: 53170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/07/2019
• Initial Date FDA Received: 08/09/2019
• Supplement Dates Manufacturer Received: 08/09/2019; 08/12/2019; 10/22/2019
• Supplement Dates FDA Received: 08/12/2019; 08/13/2019; 10/29/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/10/2018
• 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 Age: 66 YR
• Patient Weight: 113