MEDTRONIC MEXICO EUPHORA RX; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
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Catalog Number EUP3030X |
Device Problems
Deflation Problem (1149); Detachment of Device or Device Component (2907)
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Patient Problems
No Consequences Or Impact To Patient (2199); Injury (2348); Vascular Dissection (3160)
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Event Date 05/21/2020 |
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 an attempt was made to use one euphora rx ptca balloon catheter to treat a moderately tortuous, moderately calcified lesion located in the proximal left anterior descending (lad) artery, left main (lm) coronary artery and circumflex (cx) artery.The device was inspected with no issues noted.Negative prep was performed with no issues noted.The lesion was not pre-dilated.The device did not pass through a previously deployed stent.Excessive force was not used during delivery.It was reported that balloon deflation difficulties occurred and the device would not deflate at the lesion site.A non-medtronic catheter was used to remove the balloon.The patient was reported to be alive with no injury.
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Manufacturer Narrative
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Additional information: a non-medtronic guide wire was used.No resistance was noted when advancing the device.The balloon was inflated slowly at 10-12 atm.The device was not moved or repositioned when inflated.The balloon deflation difficulties occurred after the first inflation.The balloon deflated slowly, taking 5-10 seconds to deflate.A non-medtronic guide extension catheter was used to trap and remove the balloon.When removing the euphora using the non-medtronic guide extension catheter, a proximal vessel dissection occurred in the left main and left circumflex arteries.The patient was reported to be alive with no further injury.The concentration of contrast/saline used by the physician was 1:1.It was later reported that a detachment at the strain relief occurred in vivo.It was indicated that the detachment occurred when the device was positioned at the lesion.Device evaluation summary: device returned for evaluation.There was a detachment on the hypotube immediately distal to the strain relief.There was also a detachment of the entire balloon material.The material at the detachment site appeared clean and even.The detached balloon did not return for analysis.The proximal balloon bond was necked and stretched.The distal tip was damaged with the material appearing accordion like.The material at both sides of the detachment on the hypotube appeared oval and jagged.It was possible to perform deflation testing due to the condition of the returned device.There was 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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Manufacturer Narrative
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Product analysis: angiographic images confirmed moderately tortuous, moderately calcified lesion located in the proximal left anterior descending (lad) artery, left main (lm) coronary artery and circumflex (cx) artery.A balloon was delivered and inflated at the lesion site.There appeared to be issues deflating the balloon.A guide extension catheter was used to remove the inflated balloon.A dissection was noted in the left main and lcx.Product analysis:there was a detachment on the hypotube immediately distal to the strain relief.There was also a detachment of the entire balloon material.The material at the detachment site appeared clean and even.The detached balloon did not return for analysis.The proximal balloon bond was necked and stretched.The distal tip was damaged with the material appearing accordion like.The material at both sides of the detachment on the hypotube appeared oval and jagged.It was possible to perform deflation testing due to the condition of the returned device.There was no other damage evident to the remainder of the device.Additional information: detachment of the strain relief occurred after the reported deflation difficulties.It was also later reported that after the procedure the physician cut the balloon and inflated again to confirm there was a catheter occlusion.No balloon material remains in the patient.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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Search Alerts/Recalls
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