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

Catalog Number VS-402

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

Patient Problems Inflammation (1932); Pain (1994); Patient Problem/Medical Problem (2688)

Event Date 03/05/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The physician treated a patient¿s left great saphenous vein (gsv) with venaseal as per ifu with no issues.A guidewire was used for insertion of the catheter.Local anaesthesia and hand compression was used and the vein successfully closed.It was reported that the patient developed persistent inflammation in the treatment zone and experienced pain two weeks post op.There were no definitive symptoms of a hypersensitivity reaction.The physician prescribed coumadin and decided not to prescribe nsaids¿s due to a possible conflict with the patient¿s warfarin doses.It was confirmed by another physician that there is no contraindication with topical/oral steroids and so the physician decided to treat the patient using a topical nsaid first followed by an oral steroid if required.

• 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: 8407863
• MDR Text Key: 138381025
• Report Number: 9612164-2019-00825
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: VS-402
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2019
• 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): Required Intervention