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Catalog Number NCEUP2508X |
Device Problems
Burst Container or Vessel (1074); Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/17/2021 |
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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During a procedure an attempt was made to use one nc euphora balloon catheter to treat a proximal lesion.It was reported that after implantation of two stents using the "minicrush" technique, a third stent was implanted in the proximal artery and the stents were post-dilated.A guide wire was advanced towards the diagonal branch and an attempt was made to recross the nc euphora towards the diagonal branch, but was unsuccessful.Upon removal, it was observed that the balloon was perforated with the appearance of "wrinkles" on the balloon.The procedure was completed by exchanging the balloon for another device.The patient is alive with no injury.
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Manufacturer Narrative
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Additional information: the lesion was in the left coronary artery.There were no issues noted when removing the device from the hoop.The lesion was predilated.The device did not pass through a previously deployed stent.Resistance was not encountered when advancing the device and excessive force was not used.The balloon inflation pressure was below recommended nominal pressure prior to the balloon burst.Only one balloon inflation was performed but at a burst was not noticed at that time.The device was not moved or repositioned while inflated.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 evaluation.A kink was noted on the hypotube.The balloon material and the inner member were bunched.De formation was noted to the distal tip.The balloon passed negative prep.The balloon was inflated to nominal pressure of 12atm and maintained pressure.There was no burst identified on the balloon.No other damage was noted 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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Search Alerts/Recalls
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