COVIDIEN NANOCROSS ELITE 0.14 OTW PTA DILATATION CATHETER; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
|
Back to Search Results |
|
Model Number AB14W060150150 |
Device Problems
Deflation Problem (1149); Inflation Problem (1310)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 04/08/2022 |
Event Type
malfunction
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
Physician was attempting to use the nanocross elite pta balloon during procedure to treat moderately calcified lesion in the proximal left superficial femoral artery(sfa).The vessel had little tortuosity and exhibited 80% stenosis.The artery diameter was 6mm and lesion length was 60mm.A 6fr sheath and non-medtronic guidewire were used.The balloon was inflated with a non-medtronic inflation device.There was no damage noted to packaging, i.E., shelf carton, hoop/tray and no issues noted when removing the device from the hoop/tray.No damage was noted to the balloon catheter.No kinks were noted in balloon catheter or wire.It was reported that both inflation and deflation issues were noted.Balloon partially inflated then wouldn¿t deflate.There were balloon inflation difficulties at 8atm.It was reported that there were balloon deflation difficulties.Device would not deflate at the lesion site.Deflation issues noted following first inflation.Deflation issues noted during subsequent inflation.The device did not pass through a previously deployed stent.No resistance was encountered when advancing the device.It took 15 minutes of backward pressure to get balloon deflated enough to go through the sheath.No patient injury.
|
|
Manufacturer Narrative
|
Product analysis an indeflator with pressure gauge was used to inflate the balloon to nominal pressure 8 atms and rated burst pressure 14atms but the balloon would not inflate.Under a microscope, crimping marks were noted on the proximal balloon bond chamber 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.
|
|
Search Alerts/Recalls
|
|
|