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Model Number VS-404 |
Device Problem
Biocompatibility (2886)
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Patient Problems
Itching Sensation (1943); Phlebitis (2004); Rash (2033)
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Event Date 03/16/2023 |
Event Type
Injury
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Event Description
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A venaseal closure system was used for treatment of a 25-35cm segment in the great saphenous vein (gsv).Local anesthesia was used.Transducer compression was used.The lumen was flushed prior to use.The ifu was followed.A guidewire was used for insertion.Patient had a rash and itching 1 day post op.Patient received a medrol dose pack on (b)(6) 2023.Patient returned for follow up with rash on back, abdominal area and mild rash on back.Patient had phlebitis down right gsv.No further patient injury reported for this event.
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Manufacturer Narrative
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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.
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Manufacturer Narrative
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Additional information: only one leg was treated.There was no challenges or deviations related to the location of catheter tip prior to initial delivery of adhesive.The catheter tip was not positioned 5cm caudal to sfj and there was no compression of the gsv.This issue is now resolved.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.
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Manufacturer Narrative
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Image analysis 4 photos were received for review.Images 1 and 2 show photos of the patients legs.There is a bandage on the right medial thigh, to cover what is likely the original insertion location for the venaseal device that was used for treatment.Above this, we can see what appears to be a reddening and inflammation, in the outline and location of the great saphenous vein.There appears to be the presence of urticaria on both legs.Images 3 and 4 show the patients abdomen and back.Both of which show inflammation, reddness and the presence of urticaria.The photos provided for review are consistent with the reported event of a ¿rash and itching¿ on the abdominal and back area, with ¿phlebitis down right gsv¿.The reported patient experience can be confirmed.There is no indication from the images provided for evaluation that the vena seal device caused the reaction on the patients leg.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.
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