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

Catalog Number VS-402

Device Problems Detachment of Device or Device Component (2907); Material Deformation (2976)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 08/29/2018

Event Type  Injury  

Manufacturer Narrative

Sample evaluation: the venaseal kit was returned for evaluation.The following items were returned: the opened labelled shelf carton, labelled tyvek lid cover, kit tray with lid, 3cc syringe, 5cc vial of adhesive, protective transportation sheath tubing, adhesive gun, 3cc syringe filled with adhesive, catheter, dilator with 0.035¿ guidewire and the blue 7fr introducer in two pieces.Tensile stretching could be seen on the most distal segment of the blue 7fr introducer.A kink in the blue 7fr introducer was noted approximately 2.5cm distal of the blue 7fr hub¿s distal tip.The blue introducer exhibited a tensile separation at approximately 53.7cm distal of the blue 7fr introducer hub¿s distal tip.The distal segment of the blue 7fr introducer exhibited approximately 15.8cm of tensile stretching between 53.7cm and 69.5cm.The overall length of the returned blue 7fr introducer was approximately 89cm.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the physician was attempting to use a venaseal to treat the great saphenous vein (gsv) as per the ifu.The lumen was flushed prior to use.Local anesthesia and hand compression were used.It was reported the physician advanced the blue introducer into the patient but he met with extreme resistance inside the vein.He then attempted to withdraw the introducer but it became stuck inside the patient.The physician began to withdraw the introducer with force but the introducer snapped and broke apart.The physician used the blue hemostat to grab hold of a piece of the blue introducer still inside the patient and slowly withdrew 1/2 cm at a time until fully out of the body.The patient experienced extreme pain throughout the procedure.After removing the last piece of the blue introducer from the patient, the physician made the decision to end the procedure.The patient was not treated with venaseal and no glue was implanted.The procedure was not completed and no vein was treated.Patient will return at a later date for further consultation.

• 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: 7909237
• MDR Text Key: 121704290
• Report Number: 9612164-2018-02533
• 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: 09/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: VS-402
• Device Lot Number: 51794
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2018
• 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): Required Intervention
• Patient Age: 96 YR
• Patient Weight: 46