MAUDE Adverse Event Report: MEDTRONIC IRELAND VENA SEAL CLOSURE SYSTEM; LASER THERAPY PRODUCT

Catalog Number SP-101

Device Problem Biocompatibility (2886)

Patient Problem Reaction (2414)

Event Date 03/24/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Physician used venaseal for patient treatment.It is reported 10 days post procedure, the patient presented with an allergic reaction and was admitted to the hospital.The patient was injected with epinephrine but there was no improvement noted.The patient was transferred to another hospital and is still hospitalised.The patient is reported to be hospitalized for 4 weeks without observing any improvement.

Manufacturer Narrative

Additional information: the venaseal procedure was performed under the knee.The reaction was a systemic whole body allergy reaction that occurred 7 days after the procedure.The patient complained of the symptoms and the physician prescribed strong antihistamines and was administered epinephrine while in the hospital.The patient received an allergy test from an allergist at the hospital and received negative for the results.The allergist suspects that it is a venaseal dependent allergy reaction.Cyro was performed from the junction to the knee.The patient is still reported to have symptoms.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Image review: a zip folder containing 4 images dated (b)(6) 2020 were received for analysis.The images showed red rash on the patient¿s skin from different locations on the body.A further zip folder containing 19 images dated (b)(6) 2020 were received for analysis.It included 10 images along with 9 duplicate images of red rash on the patient¿s skin from different locations on the body.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VENA SEAL CLOSURE SYSTEM
• Type of Device: LASER THERAPY PRODUCT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 10037851
• MDR Text Key: 190301382
• Report Number: 9612164-2020-01819
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• PMA/PMN Number: P140018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 12/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Catalogue Number: SP-101
• Device Lot Number: 55991
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention