COVIDIEN NANOCROSS ELITE 0.14 OTW PTA DILATATION CATHETER; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
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Model Number AB14W060200150 |
Device Problems
Burst Container or Vessel (1074); Detachment of Device or Device Component (2907)
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Patient Problem
Insufficient Information (4580)
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Event Date 12/14/2021 |
Event Type
Injury
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Event Description
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Physician was attempting to use the nanocross elite pta balloon catheter during procedure to treat little calcified lesion in the mid superficial femoral artery (sfa).The vessel had no tortuosity.The artery diameter was 5.5 mm.A non medtronic 6fr sheath and 0.014'' guidewire were used.The device was inflated with a non medtronic inflation device.Saline/contrast inflation fluid was used.There was no damage noted to packaging and no issues when removing the device from the hoop/tray.The device was prepped with no issues.It was reported that there was a balloon burst/leak at the luer/hub during the first balloon inflation at 4-5 atm.All fragments of the balloon were retrieved.The device detached/cracked/fractured at balloon during removal from patient after inflations.A non medtronic snare was used to remove the detached portion.The device did not pass through a previously deployed stent and no resistance was encountered when advancing the device.After the balloon was removed with snare the procedure was completed with completion angiograms to confirm satisfactory results.No patient 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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Manufacturer Narrative
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Additional information: the balloon was not burst, it came detached from the catheter, and required a snare to retrieve.There was no vessel injury.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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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.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 guidewire stuck in the device was confirmed to be 0.014¿ and the detached balloon was confirmed as 200mm.A visual inspection of the detached balloon found that only one markerband was returned.The device was measured, and it was found to be approximately 130cm in length along with the detached 200mm balloon indicating that the device was 150cm in length and that the detachment occurred at the balloon bond.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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