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

Catalog Number SP-101

Device Problem Obstruction of Flow (2423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/13/2017

Event Type  malfunction  

Manufacturer Narrative

Evaluation of blue introducer: the blue introducer was received for evaluation.A kink to the introducer was noted approximately 14.5cm from the distal tip.A dilator from the lab was successfully loaded through the proximal segment; however the dilator could not be loaded past the lodged obstruction.The obstruction was pulled and removed from the introducer.It was discovered the stuck obstruction was the distal end of a dilator.The length of the dilator is approximately 5cm.The fracture face was straight across, consistent with the component being cut.If information is provided in the future, a supplemental report will be issued.

Event Description

The physician intended to use vena seal to treat a venous deficiency in the gsv.The device was prepped as per the ifu with no issues identified.No visible damage was noted to the device.The introducer was prepared and positioned in the patient and the dilator was removed.The glue delivery catheter was introduced and approximately halfway into the introducer, the physician experienced resistance.The surgeon tried to continue to advance but the delivery catheter would not pass through the introducer.No issue were noted when dilator had been used.The delivery catheter was removed.Surgeon checked to see if inadvertent glue deployment had occurred but the glue was still approximately 1 cm from the tip.No kinks were noted in the introducer or the catheter.The surgeon opened a second kit and replaced the introducer.The procedure was finished without further issue, one segment was treated and the vein closed.No patient injury was 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: 7074372
• MDR Text Key: 93605366
• Report Number: 9612164-2017-01696
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P140018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2019
• Device Catalogue Number: SP-101
• Device Lot Number: 47059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/12/2017
• 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