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Catalog Number AMD020150152 |
Device Problems
Deflation Problem (1149); Inflation Problem (1310); Difficult to Remove (1528)
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Patient Problem
Unspecified Tissue Injury (4559)
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Event Date 06/07/2021 |
Event Type
Injury
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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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The physician attempted to use an amphiprion deep balloon to treat a calcified, fibrous, plaque lesion in the distal anterior tibial artery.The vessel was reported as moderately tortuous and calcified with chronic total occlusion of 100%.The artery was 3mm in diameter.There were no abnormalities reported in relation to anatomy.There was no damage noted to packaging, i.E.Shelf carton, hoop/tray.There were no issues noted when removing the device from the hoop/tray.The device was not prepped per the ifu.The device did not pass through a previously-deployed stent.No resistance was encountered when advancing the device.No excessive force used.Embolic protection was not used.The balloon was inflated with a syringe.A 6 sheath and non medtronic guidewire was used.After the guide wire was in place it was expanded with 2.0 deep.It is reported that it was very difficult to withdraw the balloon after it was filled, and the process of filling was not smooth.Relatively long time to deflate the balloon.Intervention required to remove.When going out of the sheath, it was necessary to manually arrange the balloon removal under negative pressure.The device was remo ved safely.No vessel damage noted.There were no patient symptoms or complications associated with this event.
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Manufacturer Narrative
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Device evaluation the balloon returned in its post inflated state with contrast/crystalline structures visible inside the balloon chamber.A 20ml water filled syringe was connected to the device and flushed with no issues.A 0.014¿ guidewire from the lab was front loaded via the distal and exited via the gw port of the luer with no difficulty.An indeflator was connected to the device and the balloon inflated to nominal pressure (7atm) and rated burst pressure (14atm) with no difficulty.The balloon was able to hold its nominal pressure of 7atm and rated burst pressure of 14atm.A vacuum was pulled but the balloon chamber would not deflate.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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