COVIDIEN NANOCROSS 0.14 OTW PTA DILATATION CATHETER; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
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Model Number AB14W020040150 |
Device Problems
Burst Container or Vessel (1074); Use of Device Problem (1670)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/28/2021 |
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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Physician attempted to use a nanocross pta balloon during treatment of a calcified lesion in the patient¿s anterior tibial artery.There was no damage noted to packaging, i.E.Shelf carton, hoop/tray.No issues were noted when removing the device from the hoop/tray.The device was prepped as per ifu without issue.A balloon burst below nominal pressure is reported.No fragments remained in the patient.The device was used 4 days past expiration.A replacement medtronic balloon was used to complete the procedure.No patient injury reported.
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Manufacturer Narrative
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Device evaluation visual inspection under a microscope confirms that both marker bands are visible and intact.The balloon returned in its post inflated state and bunching is noted on the proximal balloon bond.Crystalline solution/contrast is visible inside the balloon profile.A 20ml water filled syringe was connected to the device however it was not possible to flush the device which may be due to the bunching on the proximal balloon bond.A 0.014¿ guidewire from the lab could not be loaded through the device.Possible biologics inside the balloon prevented the gw from being loaded.The device was connected to a pressure gauge and attempted to inflate the balloon to nominal pressure (8atm) and rated burst pressure (14atm) but the balloon failed to inflate.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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Additional information: no intervention for removal of balloon fragments.No vessel damage noted.No additional treatment required.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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