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Model Number CH06-40-75US |
Device Problem
Burst Container or Vessel (1074)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/03/2022 |
Event Type
malfunction
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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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Event Description
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According to the reporter, during procedure, the 6mm x40mm pta (percutaneous transluminal angioplasty) balloon was inflated to its r ated burst pressure (25atm) and a prolonged angioplasty was being performed.The intended time to hold the balloon was 3 minutes.At the 2 minute and 30 second mark the balloon popped and lost all inflation.The catheter was not repaired, tego was not utilized and no cleaning agents was used on the device.There was no luer adapter issue and the insertion site was treated with prior to product placement.There was a leak, and it was located where the balloon popped linear down the shaft of the catheter.The balloon was successfully removed with no harm to the patient.Although the balloon popped before the intended hold time the angioplasty was confirmed successful after removing the balloon and shooting contrast through the sheath and the device was replaced.Nothing unusual was observed on the device prior to use and insufflator/guidewire was utilized with the device.Flushing done per ifu(instruction for use).There was no other defects/damages found on the product.There was no excessive force used to pull/take out the product and the event did not result to patient having vessel damage.The balloon was inflated using contrast/saline and the device did not pass through a previously deployed stent.This was the first prolonged inflation that was applied to the device prior to the issue occurred.The balloon was pulled out through the sheath with no issue and all the balloon fragments was retrieved when the balloon burst.The procedure was completed and no further action needed.There was no blood loss and blood transfusion was not required.There was no patient symptoms or complications associated with the event.No further intervention was needed to treat the patient.There was no reported patient injury.
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Manufacturer Narrative
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Evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted the device had been used and appeared to be in dried blood in cannula.The device was severely kinked.It was reported that a balloon burst in an unknown direction.The reported issue was confirmed.The most likely cause could not be established from the information available.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.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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