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

Model Number SP-101

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Occlusion (1984); Thrombus (2101)

Event Date 12/16/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Physician used venaseal occluding device during procedure to treat 15cm of the great saphenous vein (gsv).Ifu was followed during preparation, procedure and post procedure.A guide wire was used for the insertion of the catheter.It was reported that the bilateral venaseal scheduled for the patient, tor the treatment of the left gsv was done with no issues observed.Glue catheter was removed from left leg, tip was wiped clean with a clean dry gauze.Same catheter was used for right gsv.When administering the 1st dose 6cm away from the sfj, plunger in the syringe did not move, although gun leaver was pressed firmly and held for 3 secs.Compression was maintained with an ultrasound transducer.Physician repeatedly administered 2 more doses at the same spot but, plunger did not move.A new kit from the same lot was opened.The procedure was completed with a gun and syringe of glue per ifu.30 - 35 minutes post-procedure ultrasound scan showed that cfv near the sfj was 20% occluded with 0.3mls glue, about 1 cm long segment.The procedure was converted from endo to open procedure to remove hardened glue from cfv near the sfj.No further patient injury was reported for this event.

Manufacturer Narrative

Post procedure ultrasound scan was carried out 30 - 45 minutes post-procedure.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: 9509182
• MDR Text Key: 176412958
• Report Number: 9612164-2019-05286
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: P140018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Model Number: SP-101
• Device Catalogue Number: SP-101
• Device Lot Number: 55676
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/16/2019
• Initial Date FDA Received: 12/23/2019
• Supplement Dates Manufacturer Received: 12/23/2019
• Supplement Dates FDA Received: 12/27/2019
• Date Device Manufactured: 05/07/2019
• 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
• Patient Outcome(s): Required Intervention