Model Number K09A |
Device Problems
Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 04/07/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Product was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that the patient presented with primary osteoporosis (compression fracture); and underwent balloon kyphoplasty at l5.Intra-op, after the balloon (of the inflatable bone tamp) at the right side was inflated to 120 psi, the pressure gradually started to fall.When the right balloon was inflated to 150 psi, the left balloon gradually depressurized (3-4 psi in 1 second).The balloon was inserted into the vertebral body.The surgeon checked the image when the pressure was likely to fall below 100 psi, and outflow of the contrast media from the balloon was confirmed.So, the handle was grasped and pulled to the end, and after the balloon was confirmed to be deflated, it was removed from the vertebral body.When confirmed outside the operative field, the balloon was found to be broken.Hence, another inflatable bone tamp was used to complete the procedure successfully.There was a delay of less than 60 minutes as a result of this event.No patient complications were reported as a result of this event.
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Manufacturer Narrative
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H3.Device evaluation summary: the ibt balloon was scratched.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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H3: analysis found, visual and functional inspection revealed the balloon has been ruptured.The rupture is a pinhole near the proximal peak.This rupture is consistent with the balloon coming in contact with bone spurs when the balloon is inflated in the vertebral body.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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