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Catalog Number SPL25015X |
Device Problems
Difficult to Remove (1528); Detachment of Device or Device Component (2907)
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Patient Problem
Insufficient Information (4580)
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Event Date 09/23/2021 |
Event Type
Injury
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Event Description
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An attempt was made to use a sprinter legend rx ptca balloon catheter to treat a lesion with occlusion in the lad and rca.The patient was admitted with intermittent pain in the anterior heart area and chest tightness.It was reported that during the procedure, the middle part of the balloon catheter was disconnected.The device was replaced with a new balloon.No further patient injury was reported.
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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 patient had lesions with occlusion in the lad and rca.The device was inspected before use.Resistance was not noted during delivery of the device.Excessive force was not used.The device was not kinked and re-straightened during use.The detachment occurred during withdrawal of the device from the vessel/guide catheter.Resistance was noted during withdrawal of the device, but excessive force was not used.Removal difficulties were encountered.The detached portion of the device was removed from the patient slowly and safely.It was stated that due to the disconnection, serious harm was caused to the patient.Annex a and annex g codes added initial reporter details provided patient weight provided 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.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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