Model Number KPT1502 |
Device Problems
Burst Container or Vessel (1074); Leak/Splash (1354)
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Patient Problem
Hemorrhage/Bleeding (1888)
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Event Date 10/30/2023 |
Event Type
malfunction
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Event Description
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Information was received from a healthcare professional via a manufacturer representative regarding a patient with preoperative diag nosis for primary osteoporosis.Type of fracture was compression fracture.Procedure performed was transcutaneous vertebroplasty for th12 it was reported that the left and right balloons were filled 1cc each (within 100 psi of pressure) and the image was confirmed.When additional filling was tried, the pressure dropped to 0 and rupture was observed.Both the left and right balloons may have ruptured at the same time.When the right balloon was re-inflated after being removed outside the body, a small hole was observed, and although it gradually inflated, there was a leakage of contrast medium from the hole.When the left balloon was deflated inside the body, blood from the vertebral body flowed back through the tube, and like the right balloon, it was not inflated at all when it was re-inflated outside the body.There was no patient symptoms or complications as a result of this event.There was a less than 60 minutes delay in the overall procedure time.The amount of bleeding was small in percutaneous vertebroplasty.
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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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Manufacturer Narrative
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H3.Product analysis product id # kpt1502; lot no.# 227227536 visual and functional inspection revealed the balloon has been punctured.The damage is a slice in the upper portion of the balloon.This damage is consistent with the balloon coming in contact with bone spurs when the balloon is inflated in the vertebral body.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Search Alerts/Recalls
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