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Catalog Number SBI070020080 |
Device Problem
Burst Container or Vessel (1074)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/24/2022 |
Event Type
malfunction
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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Physician was attempting to use the admiral xtreme pta balloon during procedure to treat moderately calcified lesion.The vessel exhibited 70% stenosis.The balloon was inflated with an inflation device.There was no damage noted to packaging, i.E.Shelf carton, hoop/tray and no issues were noted when removing the device from the hoop/tray.The device was prepped per ifu with no issues.No resistance was encountered when advancing the device.It was reported that there was a balloon burst during balloon just after nominal pressure.1 prior inflation had been applied to the device.All fragments of the balloon were retrieved.The procedure was completed with another balloon.No patient injury.
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Manufacturer Narrative
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Product analysis the 20mm balloon was returned in a post inflated state.The device was flushed with a 20ml water filled syringe.A 0.035 thou guidewire was loaded through the distal tip of the catheter.Using a pressure gauge, the balloon was inflated to 1 atm, and a pinhole burst was identified.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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Section a2: year valid.Additional information: the patient treatment was conducted at the common iliac artery (cia).The device did not pass through a previously-deployed stent.The balloon burst in length.The balloon did not fragment.The device was safely removed from the patient.No intervention was required for the removal of the device.There was no vessel damage 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.
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Search Alerts/Recalls
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