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Model Number NCEUP27520X |
Device Problems
Burst Container or Vessel (1074); Deflation Problem (1149); Improper or Incorrect Procedure or Method (2017); Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/21/2023 |
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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An attempt was made to use one nc euphora rx balloon catheter to treat a non-calcified lesion with 75% stenosis in the mid right coronary artery (rca).The device was not inspected.Negative prep was not performed.It was reported that balloon deflation difficulties occurred and the device would not deflate at the lesion site.It was detailed that the pressure was increased to 25atm to burst the balloon and then reduce the pressure to deflate the balloon. the patient is alive with no injury.
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Manufacturer Narrative
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Additional information: the device was inspected with no issues noted.It was not difficult to remove the protective sheath.It was not difficult to remove the packaging stylette.Resistance was not noted while advancing the device to the lesion.The balloon failed to deflate.Difficulties were not noted during inflation of the device.Deflation difficulties were noted after the first inflation.An inflation pressure of 18 atm was applied for each inflation.The device was not moved or repositioned while inflated. a balloon burst did not occur.After inflating the balloon to 25 atmospheres and deflating it, the balloon was slowly deflated and removed.Intervention was not required to remove the device from the patient.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 for analysis.Kinks were evident on the hypo-tube.The device returned with a burst on the inflation lumen p roximal to the proximal marker band.Necking was evident to the proximal balloon bond/inflation lumen.The balloon was partially inflated on device return.Contrast was not visible in the balloon.It was not possible to preform deflation testing due to the condition of the proximal bond/ inflation lumen.No deformation was evident to the distal tip.No other deformation evident to the remainder of the device.Correction: annex a code a2303.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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