COVIDIEN NANOCROSS ELITE 0.14 OTW PTA DILATATION CATHETER; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
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Catalog Number AB14W050040150 |
Device Problems
Entrapment of Device (1212); Fracture (1260); Device Damaged by Another Device (2915); Physical Resistance/Sticking (4012)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/18/2019 |
Event Type
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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Event Description
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Physician used a nanocross elite with a 6fr non-medtronic sheath and nitrex wire during treatment of a 150mm, calcified cto (chronic total occlusion-100%) in the patient¿s mid right superficial femoral artery (sfa) of diameter 6mm.Moderate vessel tortuosity and severe calcification are reported.Ifu was followed.No issues noted to packaging prior to use.No issues noted when removing he device from the packaging.The device was prepped without issue.A non-medtronic inflation device was used with heparinized saline and contrast for balloon inflation.The device was passed through a previously deployed stent without resistance.It is reported that on the second inflation when the balloon was inflated to 14atm, the device became caught on a stent.Resistance was encountered during withdrawal and excessive force was used.The balloon is reported to have fractured.A snare was used to remove the detached balloon fragment from the patient.No patient injury reported.
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Manufacturer Narrative
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Additional information: the device passed through a previously deployed 6x150 everflex stent without resistance.There were no issues caused to the stent.No further patient injury was reported for this event.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.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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