|
Model Number H1-M |
Device Problems
Detachment of Device or Device Component (2907); Difficult to Advance (2920)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 04/04/2023 |
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
|
A physician was using a hawkone atherectomy device for the treatment of a plaque lesion with 30% stenosis in the distal region of the right common iliac artery.There was no tortuosity and mild calcification.A 6fr non medtronic sheath and a 0.014" non medtronic guidewire was used.The ifu was followed.The guidewire was hydrated at preparation.The device was advanced over the bifurcation.Physician had already made 2 passes with hawk before incident occurred.While advancing for the 3rd pass he began having severe resistance.While looking under fluoro it was noted there was some wire prolapse within the common iliac and catheter would no longer advance.The wire was locked up on the nose cone of the catheter.The guidewire lumen was torn from the distal tip.The physician then carefully removed wire, catheter, and sheath collectively in tandem.The physician then used wire cutters to free the catheter from the wire to replace the sheath and continue with intervention.Upon retrieval of hawk catheter, the tip broke off but not inside of patient.No foreign body was left inside of patient.No patient injury.
|
|
Manufacturer Narrative
|
Product analysis a visual inspection showed that the tip detached distal to the anchor pockets, the detached tip was not returned a kinked 0.014¿ guidewire stuck in a 6fr sheath was also returned 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
|
|
|