Model Number 479888 |
Device Problem
Activation, Positioning or Separation Problem (2906)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/14/2023 |
Event Type
malfunction
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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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Event Description
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It was reported that that an attempt was made to use one lead and one guidewire in a non-tortuous, non-calcified lesion in the mid coronary sinus.The device was inspected with no issues noted.The wire tip was not formed by the physician.The guidewire was examined and flushed before use with no issues/kinks noted.Difficulties were not noted when loading the guidewire.No excessive force was used during insertion/delivery.It was reported that the wire got stuck inside the lead.The wire was being used as a guidewire for the left ventricle (lv) lead.The lead was positioned in the intended vessel however when attempts were made to remove the guidewire, it was stuck inside.This was the first use of the guidewire.The guidewire was being front loaded through wire entry port to start on the pacing table before entry into the guide catheter but as the wire was being withdrawn into the lead in the vein branch it ¿jammed¿ and the only way it was coming out was to remove everything as the guidewire and lead were still stuck together.The guidewire entered the patient's vasculature as it was out of the end of the lead.Other devices were in use with wire when the issue occu rred.He lv lead and the guidewire were removed.A replacement lead was successfully implanted.No patient complications have been reported as a result of this event.
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Manufacturer Narrative
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Product event summary: the full lead was returned and analyzed.Analysis indicated the distal conductor of the lead was obstructed due to a guidewire stuck in the lumen.The guidewire was kinked/buckled.Visual analysis of the lead indicated damage during use.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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Search Alerts/Recalls
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