|
Catalog Number H1-LS |
Device Problem
Physical Resistance/Sticking (4012)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 10/13/2023 |
Event Type
malfunction
|
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.
|
|
Event Description
|
Physician attempted to use a hawkone ls atherectomy device with a 6fr non-medtronic (terumo) sheath and a 4mm spider fx embolic protection device/guidewire during treatment of a 220mm calcified plaque lesion in the patient¿s right distal superficial femoral artery (sfa) popliteal artery.Artery diameter reported as 6mm.There were no abnormalities reported in relation to anatomy.Little vessel tortuosity and moderate vessel calcification are reported.The ifu (instruction for use) was followed during preparation, procedure, post-procedure.The vessel was not pre-dilated.The vessel was post-dilated.It is reported physician was unable to close the cutter window - the orange button wouldn't close the cutter window again.The position of the cutter in relation to the nosecone during device removal from the patient was half way inside housing, it wouldn¿t close all the way.The device was safely removed from the patient.No any deformation was noticed in the cutter.Physician removed hawk device and used dcb to complete procedure.No patient injury reported.
|
|
Manufacturer Narrative
|
Product analysis: the device was returned with the thumbswitch approximately halfway between the ¿on¿ and ¿off¿ position, and the cutter was positioned at the distal end of the cutter window.The thumbswitch was fully retracted, and the cutter returned to the cutter window and rotated.The thumbswitch was advanced but the cutter could only advance approximately 17mm into housing where it stopped.A visual inspection found damage to the pet liner distal to where the cutter stopped which prevented the cutter from fully advancing.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
|
|
|