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

Catalog Number VS-402

Device Problems Defective Component (2292); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/26/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Physician intended to use a venaseal kit for treatment of the patient¿s great saphenous vein (gsv).Ifu was followed.It is reported that the white sheath became stuck, the physician was unable to remove the inner portion, it broke off as the physician attempted to remove it.Resulting in everything being removed as a unit.All pieces were accounted for no intervention was required, no glue was administered.A new venaseal kit was opened to complete the procedure.No injury reported.

Manufacturer Narrative

Product analysis: the venaseal components were returned.Components returned for evaluation include: a blue introducer, a stretched dilator and a micro introducer.The dilator was stretched and a portion was detached.The detached portion of the dilator was stuck within the blue introducer.A kink and compression was observed on the blue introducer just proximal of the introducer hub.The blue introducer was skived and the distal end of the dilator was retrieved.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: 8933822
• MDR Text Key: 155690472
• Report Number: 9612164-2019-03574
• 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
• Report Date: 10/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: VS-402
• Device Lot Number: 55076
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/19/2019
• Initial Date FDA Received: 08/27/2019
• Supplement Dates Manufacturer Received: 10/21/2019
• Supplement Dates FDA Received: 10/29/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/26/2019
• 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: 83 YR