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Model Number CH08-40-75US |
Device Problems
Detachment of Device or Device Component (2907); Difficult to Open or Remove Packaging Material (2922); Device Fell (4014)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/22/2021 |
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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According to the reporter, prior to use, during removal of the device from the protective packaging, the distal sleeve/ protective packaging around balloon was too tight, it caused the balloon to come off from the shaft, no excessive force used and the detachment was spontaneous.The product was not used, set it to side as it was defective, it was replaced with another balloon (competitor¿s brand) and the procedure was completed.There was no damage to the device's box and packaging and nothing unusual observed on the device aside from reported issue.The device was not repaired, no leak, no cleaning agent used, and no luer adapter issue.There was no patient injury.
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Event Description
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According to the reporter, prior to use, during removal of the device from the protective packaging, the distal sleeve/ protective packaging around balloon was too tight, it caused the balloon to come off from the shaft, no excessive force used and the detachment was spontaneous.The product was not used, set it to side as it was defective, it was replaced with another balloon (competitor¿s brand) on the same day of the event and the procedure was completed.There was no damage to the device's box and packaging and nothing unusual observed on the device aside from reported issue.The device was not repaired, no leak, no cleaning agent used, and no luer adapter issue.There was no patient injury.
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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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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, prior to use, during removal of the device from the protective packaging, the distal sleeve/ protective packaging around balloon was too tight, it caused the balloon to come off from the shaft, no excessive force used and the detachment was spontaneous.The product was not used, set it to side as it was defective, it was replaced with another balloon (competitor¿s brand) on the same day of the event and the procedure was completed.There was no damage to the device's box and packaging and nothing unusual observed on the device aside from reported issue.The device was not repaired, no leak, no tego utilized, no cleaning agent used, and no luer adapter issue.There was no patient injury.
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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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Evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted the introducer sheath was found to be the incorrect size.It was reported that there was detachment of the balloon.The reported issue was confirmed.The most likely cause was determined to be manufacturing related.Internal process improvements have been initiated to mitigate this issue.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, prior to use, during removal of the device from the protective packaging, the distal sleeve/ protective packaging around balloon was too tight, it caused the balloon to come off from the shaft, no excessive force used and the detachment was spontaneous.There was no damage to the device's box and packaging and nothing unusual observed on the device aside from reported issue.The device was not repaired, no leak, no tego utilized, no cleaning agent used, and no luer adapter issue.The product was not used, set it to side as it was defective, it was replaced with another balloon (competitor¿s brand) on the same day of the event and the procedure was completed.There was no patient injury.
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Search Alerts/Recalls
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