MAUDE Adverse Event Report: SAPHEON / MEDTRONIC 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 02/09/2015

Event Type  Injury  

Event Description

Procedure was performed in (b)(6).Customer stated that a patient contacted his facility on (b)(6) 2015, to ask if there have been any reports of acute psychosis in post venaseal treatments.Patient treated with venaseal has been referred for psychiatric evaluation due to extreme euphoria post treatment.After further investigation, the patient was diagnosed with bipolar affective disorder.His post procedure duplex scan demonstrates and excellent result with closurefast cather from 3cm beyond the junction bilaterally with no evidence of dvt.

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).Results: adhesive.

Manufacturer Narrative

(b)(6).Customer stated that a patient contacted his facility on (b)(6) 2015, to ask if there have been any reports of acute psychosis in post venaseal treatments.Patient treated with venaseal has been referred for psychiatric evaluation due to extreme euphoria post treatment.After further investigation, the patient was diagnosed with bipolar affective disorder.His post procedure duplex scan demonstrates and excellent result with venaseal closure system from 3cm beyond the junction bilaterally with no evidence of dvt.

Manufacturer Narrative

This mdr is being submitted as a part of a retrospective review / remediation effort performed at the covidien (b)(4) location, following medtronic¿s acquisition of covidien.  a capa has been opened to manage the actins related to remediation of complaint files and any required mdr reporting.

• Brand Name: VENASEAL CLOSURE SYSTEM-CE MARK
• Type of Device: AGENT, OCCLUDING, VASCULAR, PERMANENT
• Manufacturer (Section D): SAPHEON / MEDTRONIC; 951 aviation parkway; morrisville NC 27560
• Manufacturer (Section G): SAPHEON/MEDTRONIC; 951 aviation parkway; morrisville NC 27560
• Manufacturer Contact: 33987000
• MDR Report Key: 4841327
• MDR Text Key: 5940230
• Report Number: 3011410703-2015-00004
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: P140018
• 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,Followup
• Report Date: 04/02/2015

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 Expiration Date: 05/01/2016
• Device Model Number: SP-101
• Device Catalogue Number: SP-101
• Device Lot Number: 38407
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/04/2015
• Initial Date FDA Received: 06/12/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 08/04/2015; 03/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2014
• 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): Other