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Catalog Number AMD025080152 |
Device Problems
Deflation Problem (1149); Inflation Problem (1310); Difficult to Remove (1528)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/30/2024 |
Event Type
malfunction
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Event Description
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Physician attempted to use an amphirion deep pta balloon during patient treatment.There were no abnormalities reported in relation to anatomy.No embolic protection was used.The ifu (instruction for use) was followed and the device was prepped without issue.Itwas reported balloon inflation difficulties were noted during balloon inflation.The amphirion deep balloon could not be fully opened along its entire length.Balloon deflation difficulties also occurred following first inflation.The device would not deflate at the lesion site.Difficulty removing balloon through the sheath following balloon inflation was also reported.No patient injury reported.
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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 infomration: 6fr sheath and 0.014 inch guidewire was used during procedure.There was no damage noted to packaging and no issues were noted when removing the device from the hoop/tray.Balloon was inflated with inflation device and 50% saline 50% contrast inflation fluid was used.The device did not pass through a previously-deployed stent.It was reported that inflation difficulties were noted at 8atm during balloon inflation.No resistance encountered when advancing the device.Balloon catheter did not catch upon the sheath during withdrawal.Device was pulled with resistance for removal and was safely remove from patient with no vessel damage.Procedure was completed with a non-medtronic balloon.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 the device was returned with the balloon in a post-inflated state.The device was flushed, and a 0.014¿ guidewire was loaded.The balloon could not be inflated, and a visual inspection found that the outer shaft was stretched adjacent to the balloon bond preventing inflation.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Search Alerts/Recalls
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