|
Model Number H1-M |
Device Problems
Difficult to Remove (1528); Material Deformation (2976)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 02/06/2023 |
Event Type
malfunction
|
Event Description
|
Physician was attempting to use a hawkone m atherectomy device along with a 6/65 non-medtronic sheath and a non-medtronic guidewire during procedure to treat a 100mm fibrous plaque lesion in the patients left mid proximal superficial femoral artery (sfa).Little vessel tortuosity and moderate vessel calcification are reported.Lesion exhibited 80% stenosis.Artery diameter is reported as 5mm.The vessel was pre and post dilated.The ifu (instruction for use) was followed during preparation, procedure, post-procedure.Tip damage is reported.The tip did not separate at hinge pin.After packing the nosecone the plaque filling comes through the nitinol slightly.Nitinol wart due to potential overpacking.Moderate resistance was felt during withdrawal.Resistance was not felt during advancement.The flush port on catheter handle was not damaged.Hawking was finished when issue noted.No patient injury reported.
|
|
Manufacturer Narrative
|
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.
|
|
Manufacturer Narrative
|
Additional information: the tecothane jacket was intact for the most part just bulging of the nitinol.No tears/punctures/cuts were noted just more bulging.The guidewire lumen was not torn or ripped.The damaged component remained attached.The device was safely removed from the patient, with no vessel damage.Product analysis the cutter driver was attached to the device, and it was found that the thumbswitch was halfway between the ¿on¿ and ¿off¿ position, an inspection found biologics in the housing the cutter is approx.10mm inside housing and there is a bulge containing biologics approximately 18 to 20mm from the cutter window.The housing wall and the tecothane are still intact 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
|
|
|