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

Catalog Number SP-101

Device Problems Break (1069); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/26/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Physician used a vena seal kit for the treatment of the patient¿s great saphenous vein (gsv) <(>&<)> short saphenous vein (ssv) in the same leg.Ifu was followed, the device was prepped without issue.A guidewire was used for the insertion of the catheter.The procedure was carried out successfully and 18cm of the gsv and 15cm of the ssv were treated and the veins closed.No additional treatment was required.On removal of the device from the patient the introducer was observed to be broken.The physician reported that all pieces of the device were accounted for and that no pieces have been left inside the patient.The patient was reported as feeling good and without issue.No patient injury was reported.

Manufacturer Narrative

Two photographic images of the distal end of the blue introducer sheath were provided for evaluation.In both of the images a tear in the distal tip is present and the tear appears to have formed a flap in the blue introducer sheath.From the two images it appears that all components of the blue introducer sheath are accounted for.The device, including the dispenser gun, blue introducer and a 91cm catheter was returned for evaluation.Evaluation of the dispenser gun confirmed no abnormalities and the gun was fully functional.During evaluation of the catheter, biological material which had occluded inside the tubing was observed at the distal end of the white catheter.During visual inspection of the blue introducer sheath, a tear in distal tip was observed which appears to have formed a flap in the blue introducer sheath.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: 7435492
• MDR Text Key: 105676493
• Report Number: 9612164-2018-00802
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 05/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Catalogue Number: SP-101
• Device Lot Number: 48528
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/02/2017
• 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: 45 YR