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

Model Number VS-404

Device Problem Biocompatibility (2886)

Patient Problems Cellulitis (1768); Local Reaction (2035)

Event Date 08/03/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The physician used a venaseal closure system to treat the great saphenous vein of a patient.The ifu (instruction for use) was followed during preparation, procedure, post-procedure.Local anesthesia was used.A guidewire was used for the insertion of the catheter.The procedure was completed as normal.The total volume of glue used is unknown.The field employee and clinical specialist supporting the case noted that the vessel appeared to be closed based on the brief ultrasound conducted immediately following the procedure; however, this has not been confirmed by the physician office.It is reported the patient is being treated for cellulitis post procedure.The reaction was noted a period of a few days post procedure.The onset of symptoms was noted a few days post operation.The patient was admitted to the hospital according to the physician and treated accordingly.It is unknown if the patient is on any medication.The last update the physician received was that the patient was in the hospital for treatment of the cellulitis.Physician confirmed that venaseal indeed was considered an implant as patient still experiencing allergic reaction post venaseal procedure.

• Brand Name: VENA SEAL CLOSURE SYSTEM
• Type of Device: AGENT, OCCLUDING, VASCULAR, PERMANENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 12369396
• MDR Text Key: 268193645
• Report Number: 9612164-2021-03301
• Device Sequence Number: 1
• Product Code: PJQ
• UDI-Device Identifier: 00763000240776
• UDI-Public: 00763000240776
• 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: 08/26/2021

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: 01/31/2023
• Device Model Number: VS-404
• Device Catalogue Number: VS-404
• Device Lot Number: 62510
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/03/2021
• Initial Date FDA Received: 08/26/2021
• Date Device Manufactured: 01/22/2021
• 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): Hospitalization