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

Catalog Number VS-402

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Reaction (2414)

Event Date 01/21/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

During procedure, physician used venaseal occluding device to treat a segment in the great saphenous vein (gsv).Six days later, patient was admitted and treated with antibiotics and medrol dose pac, patient also on keflex.Physician noted that if no improvement, patient might need incision and drainage of distal thigh.

Manufacturer Narrative

Additional information: there were no challenges or deviations related to the location of the catheter tip prior to the initial delivery of adhesive.The catheter tip was 5 cm caudal to the sfj.The patient is reported to be doing better and the affected area is draining clear.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Image review: two photos of the patients leg was received for analysis.The photos show redness at the suspected insertion location.The observed redness shows characteristics of a potential infection.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: the physician provided a referral to an infection disease specialist.There is no update on whether the patient has gone to the specialist yet or not.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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: 9659751
• MDR Text Key: 186186049
• Report Number: 9612164-2020-00526
• 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,Followup
• Report Date: 03/20/2020

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: 11/30/2020
• Device Catalogue Number: VS-402
• Device Lot Number: 53718
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/31/2020
• Initial Date FDA Received: 02/03/2020
• Supplement Dates Manufacturer Received: 02/03/2020; 02/19/2020; 03/07/2020; 03/16/2020
• Supplement Dates FDA Received: 02/05/2020; 02/24/2020; 03/10/2020; 03/20/2020
• Date Device Manufactured: 11/26/2018
• 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): Required Intervention