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

Catalog Number VS-403

Device Problem Biocompatibility (2886)

Patient Problems Erythema (1840); Hematoma (1884); Unspecified Infection (1930)

Event Date 07/19/2023

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

A venaseal closure system was used for cac therapy of the great saphenous vein (right gsv).The ifu was followed.The lumen was flushed prior to use.No challenges or deviations related to the location of the catheter tip prior to initial delivery of adhesive.The catheter tip was 5cm caudal to sfj and compression of gsv.The degree of blood vessel articulation was strong.It was reported no hypersensitivity was observed during the follow-up echocardiogram medical consultation on 2nd day and the 7th day after the surgery, and occlusion of the target vein was also confirmed.Two weeks after the operation, redness was observed, analgesic and antibiotics were prescribed.Steroid ointment prescribed 2 days later.3 weeks after the surgery, a hematoma-like object was observed at the puncture site in the proximal nervous system of the right calf.Immediately after incision and pus drainage the redness subsided considerably.The vein was removed in the relevant area with a closed suction bag placement also, the amount of waste liquid/pus was confirmed as almost 0ml.Confirmed to be sterilized after tissue culture.Patient received consultation from the physician 2 days later.The epidermis was incised again and the surrounding tissue was resected.Patient was scheduled to return to facility to check the postscript of the reddened site.No further patient status update at this time.

Manufacturer Narrative

Product analysis: four film images were received for received for review.Image 1: ¿film image received of patient whose leg appears to have adverse reaction occurring on their leg (redness and bruising seemingly pr esent), consistent with the reported event.¿ film image 2: ¿film image received of patient whose leg appears to have adverse reaction occurring on their leg (redness and bruising seemingly pr esent), consistent with the reported event.¿ image 3: ¿film image received of patient whose leg appears to have adverse reaction occurring on their leg (slight redness/bruising seemingly present along their calf muscle), consistent with the reported event.¿ image 4 ¿film image received of patient whose leg appears to have adverse reaction occurring on their leg (open wound apparent on leg and is seemingly infected), consistent with the reported event.¿ 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: VENASEAL CLOSURE SYSTEM
• Type of Device: AGENT, OCCLUDING, VASCULAR, PERMANENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 17507836
• MDR Text Key: 320863510
• Report Number: 9612164-2023-03644
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P140018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: VS-403
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/30/2023
• 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
• Patient Age: 66 YR
• Patient Sex: Female