MEDTRONIC MEXICO NC EUPHORA RX; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
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Catalog Number NCEUP3008X |
Device Problem
Fracture (1260)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/03/2020 |
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, a nc euphora ptca balloon catheter was used to treat a lesion.The device was inspected with no issues noted.Negative prep was performed with no issues noted.The device did pass through a previously deployed stent.It was reported that the nc euphora balloon was used to post dilate the stent.It was stated that when the balloon was removed post inflation, the shaft was fractured.No patient injury was reported.
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Manufacturer Narrative
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Additional information: the lesion was in the distal lad had mild calcification, mild stenosis and mild degree of vessel tortuosity.Resistance was noted during withdrawal of the device.Sufficient time was given for the balloon to deflate prior attempting to remove the device from the patient.The detachment occurred after it was removed from the patient's body.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 summary: the device returned with a detachment on the hypotube distal to the strain relief.The hypotube material was oval and jagged on both sides of the detachment site.Slight deformation was evident to the distal tip.The balloon folds were expanded, and contrast was visible in the balloon.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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