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Model Number H1-M |
Device Problems
Detachment of Device or Device Component (2907); Difficult to Advance (2920)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/09/2021 |
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 was attempting to use hawkone directional atherectomy along with a non-medtronic 6fr sheath, spider fx 3mm guidewire and embolic protection during procedure to treat a severely calcified lesion in the left distal popliteal artery with 70% stenosis.The vessel was severely tortuous.The vessel diameter and lesion length are 4mm and 60mm respectively.The vessel was pre and post dilated.Ifu was followed.During second advancement, severe resistance was felt and the device was unable to cross and the tip detached at the hinge pin.The guidewire prolapsed and caused the tip damage.The entire nosecone detached from the catheter portion of the hawkone device.It was reported that the body of the nosecone was retrieved by pulling the spider 3mmx320mm back into the nosecone and into the sheath.Everything was captured within the sheath and the sheath with the nosecone and the embolic protection within the sheath as one unit.A non-medtronic 0.018" 3mmx40mm balloon was able to cross.The patient was okay after this event, physician was able to continue with the case with angioplasty of the lesion.There was no patient injury.
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Manufacturer Narrative
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Additional information: it is reported that part of the spider wire is still attached to the nosecone portion of the device.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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Image review: there were 5 images returned by the customer.Image 1 appears to show the distal end of a sheath, the housing and tip of the hawkone device.Image 2 appears to show basket and radiopaque marker of the spider fx device.Image 3 appears to show the distal end of a sheath and a guidewire.Image 4 appears to show the distal end of a sheath and a guidewire.Image 5 show the distal end of the hawkone torque shaft with hinge pins.The driveshaft with cutter is extending out of the torque shaft.Product analysis: the hawkone device was returned to the medtronic investigation lab for evaluation.The device was returned coiled inside a biohazard bag, detached tip and distal section of spider returned in biohazard bag with both inside a non-medtronic pouch inside 3 biohazard bags.Visual inspection confirms that the housing has detached distal to the anchor pockets.The detached tip was confirmed to be loaded on the distal section of the spider fx wire.No functional testing could be carried out.The detachment occurred adjacent to the anchor pockets, not at the hinge pins.The hinge pins are still on the catheter shaft.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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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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Search Alerts/Recalls
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