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

Catalog Number UNK-PLY-VENASEAL

Device Problems Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypersensitivity/Allergic reaction (1907); Patient Problem/Medical Problem (2688)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The glue was injected subcutaneously into the patients left arm by a physician to see if patient would have a reaction.The glue used was leftover venaseal from a previous case.Patient subsequently had a reaction since the subcutaneous injection.Patient now has a nodule on arm where glue was injected.Feels like a bump in the arm.Physician is concerned that the reaction could end up being more systemic.Patient is being monitored at the minute.No medical/surgical intervention to date.Physician is considering excising the nodule/adhesive with the intent to alleviate the symptoms.

Manufacturer Narrative

Additional information: patient had glue excised.Excision went well.Physician reports the surrounding tissues looked healthy enough to close.Patient had stitches removed at follow-up appointment post excision procedure.Patient is reported to be healing well and has noted that symptoms are lessening post removal of the glue.A venous reflux study was conducted to assess for documentable reflux, and patient has been recommended to have bilateral saphenous ablations due to minor segmental reflux in the mid-thigh of the right leg.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: reflux study conducted on the lower extremities.Patient had segmental reflux in the mid and distal thigh in the right great saphenous vein only.There were also no measurable varicose veins.Considering the patient¿s symptoms and minimal reflux, no treatment was recommended on this patient¿s minimal disease.Symptoms were related to ankle sprain.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: 8851254
• MDR Text Key: 152954045
• Report Number: 9612164-2019-03187
• 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,Followup,Followup
• Report Date: 01/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK-PLY-VENASEAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/09/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1