Catalog Number SP-101 |
Device Problems
Complete Blockage (1094); Detachment of Device or Device Component (2907)
|
Patient Problems
No Consequences Or Impact To Patient (2199); Injury (2348); Unspecified Tissue Injury (4559)
|
Event Date 09/21/2020 |
Event Type
Injury
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
Physician intended to use a venaseal kit during treatment of the patient¿s great saphenous vein (gsv).Ifu was followed.A guidewire was used for insertion of the catheter.It is reported that the end of grey dilator was blocked, so guide wire did not come out from dilator.This issue was noted prior to filling adhesive.It is reported the physician tried several times to pass through the guide wire, with it finally passing after several attempts.During the procedure it is further reported when removing the blue introducer and delivery catheter together from the vein, the blue introducer broke in the vein.The physician successfully removed all fractured pieces.No additional treatment was required.No patient injury reported.
|
|
Manufacturer Narrative
|
Product analysis: the blue introducer and dilator were returned to medtronic investigation lab for evaluation.The components were returned packaged within a clear biohazard bag.The dilator was received inserted within the blue introducer.The components were removed from the packaging for additional analysis.Visual inspection of the blue introducer reveal no physical damage or deformity.The distal tip of the blue introducer was present.It should be noted the catheter was not returned to analysis lab.Visual inspection of the dilator reveal no abnormalities or deformity.The dilator was flushed and it was observed blood residue was observed exiting the distal tip of the dilator.The dilator was flushed successfully until clear fluid was observed exiting the distal tip.A 0.035in guidewire was inserted through the distal tip of the grey dilator.The guidewire would advanced within the dilator and would exit the hub of the dilator.Post flushing, dilator was flushed successfully to remove the occluded material.The returned dilator showed dried red blood residue occluded within the dilator lumen.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.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.
|
|
Manufacturer Narrative
|
Additional information: the blue introducer detached in the vein and the detached pieces were removed with a forcep.No vessel damage was noted.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.
|
|
Search Alerts/Recalls
|
|