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

Catalog Number VS-402

Device Problems Material Puncture/Hole (1504); Deformation Due to Compressive Stress (2889)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/26/2018

Event Type  Injury  

Manufacturer Narrative

The component catheter was returned for evaluation.No other components were returned.Visual inspection of the catheter revealed an occlusion approximately 1cm proximal from the distal tip and a kink, tear and rupture of the catheter was observed approximately 23.1cm proximal from the distal tip.If information is provided in the future, a supplemental report will be issued.

Event Description

The physician intended to use the venaseal to treat the short saphenous vein as per ifu.The physician inserted the delivery catheter into the patient, the ultrasound noted that glue was exiting the side of catheter through a hole and not out of the distal tip as normal.Glue leaking from the side entered the patient.It is unknown if glue was delivered to an unintended treatment area.It was reported a kink in the catheter was observed.Another venaseal was used to complete the procedure.No patient injury reported.

• 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: 8109725
• MDR Text Key: 128560010
• Report Number: 9612164-2018-03380
• 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: 11/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2020
• Device Catalogue Number: VS-402
• Device Lot Number: 52445
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/31/2018
• Date Device Manufactured: 08/20/2018
• 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): Other
• Patient Age: 75 YR
• Patient Weight: 95