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Model Number NCEUP4512X |
Device Problems
Burst Container or Vessel (1074); Inflation Problem (1310); Detachment of Device or Device Component (2907)
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Patient Problems
Device Embedded In Tissue or Plaque (3165); Insufficient Information (4580)
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Event Date 12/16/2022 |
Event Type
Injury
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Manufacturer Narrative
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3 photos were provided - one photo of shelf carton label confirming the reported product identification.Two photos of the device - suggesting that the distal inflation lumen may have expanded and burst.There is blood present in the inflation lumen.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 ptca balloon catheter to treat a lesion in the proximal right coronary artery (rca), via a transradial approach.The device was inspected with no issues noted.The device was being used to post-dilated a deployed stent.It was reported that inflation difficulties occurred during balloon inflation.When an attempt was made to inflate the balloon there was no resistance.A balloon burst was encountered at nominal pressure and the balloon separated from catheter shaft.When the device was withdrawn for inspection it was noted that the balloon had 'broken off' and only the balloon catheter came back.The balloon was located via the marker bands.An attempt was made to snare the balloon but the balloon lodged in the wrist.The vascular surgeon was called.The patient is described as ok and no further injury reported.
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Manufacturer Narrative
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Product analysis: the device was received for analysis.Kinks were evident on the hypotube.The device returned with the inner member detached distal to the exchange joint.The detached inner member did not return for analysis.Blood was visible in the inflation lumen.A complete radial burst occurred on the proximal end of the balloon.It appeared that the balloon bond expanded leading to the burst.The balloon material was jagged and uneven at the burst site.The detached balloon material did not return for analysis.Inflation testing could not be carried out due to the condition of the device.No other damage evident to the remainder of the device.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 information: the detached portion of the balloon catheter remains in the patient.The patient was brought back the next day to expand the stent.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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