MAUDE Adverse Event Report: COVIDIEN LLC VENA SEAL CLOSURE SYSTEM; AGENT, OCCLUDING, VASCULAR, PERMANENT

Model Number SP-101

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/10/2017

Event Type  malfunction  

Event Description

It was reported that the physician used a venaseal device during a procedure for treatment of venous reflux.When the catheter was inserted in the first vein to be treated, the vessel presented a spasm, which made it difficult to advance.It was reported that the physician had to withdraw the catheter with its respective dilator inside.It was reported that the centimetric catheter had stretched to the same size as the dilator that was inside.In order to continue the procedure, the physician proceeded to cut the catheter and verified the measurements and distances were suitable to carry out the procedure correctly.No patient injury was reported.It was reported that the current status of the patient is well.It was reported that the product was discarded, because it was contaminated.

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): COVIDIEN LLC; 951 aviation parkway; morrisville NC 27560
• Manufacturer (Section G): COVIDIEN LLC; 951 aviation parkway; morrisville NC 27560
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 6322608
• MDR Text Key: 67208840
• Report Number: 3011410703-2017-00008
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• Reporter Country Code: CI
• PMA/PMN Number: P140018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2017
• Device Model Number: SP-101
• Device Lot Number: 42362
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/12/2017
• Initial Date FDA Received: 02/10/2017
• Supplement Dates Manufacturer Received: Not provided; 02/10/2017
• Supplement Dates FDA Received: 03/10/2017; 09/29/2017
• Date Device Manufactured: 11/25/2015
• 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: 38 YR
• Patient Weight: 67