MAUDE Adverse Event Report: MORRISVILLE VENASEAL CLOSURE SYSTEM-CE MARK; AGENT, OCCLUDING, VASCULAR, PERMANENT

Model Number SP-101

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 12/05/2014

Event Type  Injury  

Event Description

This procedure was performed in (b)(6).Customer reported a patient had a plug of removed from the entry site after a venaseal procedure.The customer has kept the plug and asked medtronic to find out if it was venaseal adhesive.The patient was unharmed and no treatment or intervention was taken.

Manufacturer Narrative

A review of the manufacturing records for this device did not reveal any discrepancies relevant to the reported event.Additional information has been requested, should it become available a supplemental report will be submitted.(b)(4).

Manufacturer Narrative

This is a correction to the initial mdr with date of this report 01-jul-2015.The initial mdr incorrectly stated "a review of the manufacturing records for this device did not reveal any discrepancies relevant to the reported event." a review of the manufacturing records was not performed due to a lot number not being received from the user facility.

• Brand Name: VENASEAL CLOSURE SYSTEM-CE MARK
• Type of Device: AGENT, OCCLUDING, VASCULAR, PERMANENT
• Manufacturer (Section D): MORRISVILLE; 951 aviation parkway; morrisville NC 27560
• Manufacturer (Section G): MORRISVILLE; 951 aviation parkway; morrisville NC 27560
• Manufacturer Contact: 15 hampshire st; mansfield, MA 02048 ; 33987000
• MDR Report Key: 4957485
• MDR Text Key: 6037934
• Report Number: 3011410703-2015-00005
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative,company representati
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/01/2015

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 Model Number: SP-101
• Device Catalogue Number: SP-101
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/01/2015
• Initial Date FDA Received: 07/31/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other