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Model Number NCSP3512X |
Device Problems
Burst Container or Vessel (1074); Leak/Splash (1354); Material Split, Cut or Torn (4008)
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Patient Problem
Vascular Dissection (3160)
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Event Date 11/20/2023 |
Event Type
Injury
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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.
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Event Description
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An attempt was made to use one nc sprinter rx balloon catheter to treat a severely calcified lesion with 100% chronic total occlusion (cto).The device was not inspected.Negative prep was not performed.The lesion was pre-dilated.The device passed through a previously deployed stent.Resistance was not encountered when advancing the device.Excessive force was not used during delivery.It was reported that a balloon burst, leak or catheter leak occurred during inflation at 6-8atm.It was stated that a blood vessel dissection occurred.No further patient injury occurred.
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Manufacturer Narrative
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Additional information: the lesion being treated had a moderate degree of vessel tortuosity and was located in the anterior descending artery.The device was being used to post-dilate a deployed stent.It was later confirmed that a balloon leak occurred.The device was moved or repositioned in the lesion prior to the leak.Two inflations were performed before the issue occurred.It was believed that the dissection may be related to the leaking balloon, possibly due to the pressure of the leaking fluid impacting the balloon.An additional stent was implanted at the dissection location to treat it.After withdrawing the nc sprinter balloon from the patient's body, the surgery was completed with a non-mdt 3.5*12mm post-inflation 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 for analysis.The device returned with balloon folds partially expanded.Residue was visible in the balloon.The device was placed in the water bath to disperse the residue in the balloon in order to aid device pressurization.The balloon failed negative prep.On pressurization of the device, liquid was observed exiting the balloon distal cone, over the distal marker band.The balloon failed to inflate.Upon visual inspection of the device, a short longitudinal tear was observed on the balloon material, exiting the balloon distal cone, over the distal marker band.The balloon material was jagged and uneven at the tear site.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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Search Alerts/Recalls
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