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

Catalog Number SP-101

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

Patient Problems Fever (1858); Unspecified Infection (1930); Sepsis (2067); Patient Problem/Medical Problem (2688)

Event Date 11/07/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The physician used the venaseal to treat the right great saphenous vein (gsv) and short saphenous vein (ssv) as per ifu.Hand compression was used.The access site was positioned low down on the calf.The catheter tip was approximately 5cm caudal to the sapheno femoral junction (sfj).0.8ml of venaseal was used on the right ssv and 2.2ml on the right gsv.A total of 20cm of the ssv and 61cm of the gsv were treated.It was reported the patient was admitted to the emergency department on (b)(6) 2018 as a regular cellulitis patient with the access site exuding puss.Patient also presented with sepsis and fever.The patient was transferred to the vascular ward on (b)(6) 2018.Cellulitis was confirmed because of staph aureus bacteria in the blood and on the wound swabs.Spots of redness on the calf were observed; the back of calf was observed to be very red.Surgical drainage was carried out on (b)(6), one above the medial malleolus at the entry site of the catheter and one in the mid-calf.Patient was discharged from hospital on (b)(6) and is receiving treatment for a total of 6 weeks of iv antibiotics.

Manufacturer Narrative

Image analysis: no components from the venaseal closure system kit was received for evaluation.No photographic images of the patient¿s symptoms were received for evaluation.Three folders of sonographic images were received.One folder is pre-operative (2018.06.08) and contains 40 sonographic images.Two folders are post-operative, (2018.11.09 and 2018.11.15).One of the post operative folders contains an ultrasound worksheet and 35 sonographic images from the (b)(6) 2018 visit.The other post operative folder contains 5 sonographic images from the (b)(6) 2018 visit.In the post-operative images occlusion of the great saphenous vein(gsv) and the short saphenous vein(ssv) can be seen.The ultrasound work sheet indicates that two samples less than 2ml were taken from the mid and distal calf on the (b)(6) visit.The worksheet indicates that the gsv is fully occluded from 7mm below the saphenofemoral junction(sfj) to the distal calf.The worksheet also indicates that the ssv is fully occluded from the popliteal junction to the distal calf.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: 8133993
• MDR Text Key: 129364380
• Report Number: 9612164-2018-03479
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SP-101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2018
• 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): Hospitalization; Required Intervention
• Patient Age: 55 YR