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Catalog Number SBI040020130 |
Device Problems
Burst Container or Vessel (1074); Inflation Problem (1310); Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/01/2022 |
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 an admiral xtreme pta balloon during procedure to treat a lesion in the biliary artery.No embolic protection was used.It is unknown what inflation device was used for balloon inflation.There was no damage noted to packaging.There was no issue noted when removing the device from hoop/tray.The device was prepped per ifu with no issues identified.It was reported that physician flushed out the lumen for the guidewire by connecting a syringe filled with saline solution and flushing until guidewire lumen at the distal tip.Balloon burst, leak or rupture occurred during balloon inflation.Physician inflated balloon to 2atm and realised that the balloon was damaged so did not continue and took it out at that moment.Physician perceived the balloon was bad and did not do anything with the balloon.All fragments of the balloon was retrieved.Balloon inflation difficulties was also observed during balloon inflation.The device did not pass through a previously deployed stent.Physician used an admiral xtreme measuring 5 x 120 and then a 7 x 20 without any problem and the procedure was completed.There were no abnormalities reported in relation to anatomy.There was no medical or surgical intervention needed.The event did not lead to or extend patient's hospitalization.There was no patient injury.
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Manufacturer Narrative
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Additional information: there was a pin hole balloon leak prior to use.The device didn¿t enter the patient.No intervention required.The balloon did not fragment.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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Product analysis a 20mm balloon was returned in a post-inflated state.The device was flushed with a 20ml water filled syringe (photo 7).A 0.035 thou guide wire was loaded through the distal tip of the catheter.Using a pressure gauge an attempt was made to inflate the balloon, a leak was observed before reaching 1atm.A longitudinal tear was observed across the length of the balloon under microscopic inspection.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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