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Model Number H1-M |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
Patient Problem/Medical Problem (2688)
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Event Date 02/26/2019 |
Event Type
Injury
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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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It was reported that a physician was attempting to use a hawk one atherectomy device to treat a lesion in the left prox superficial femoral artery with moderate calcification and tortuosity with 75% stenosis.Sheath french size and brand was 6f destination, size of embolic protection used was 6, vessel was not pre-dilated or post-dilated, ifu (instruction for use) was followed during preparation, procedure, post-procedure.It was reported that the tip detached during the procedure during withdrawal.Minimal resistance was experienced.The tip separated at hinge pin with complete separation and broke off while taking the device out of the body.Procedure was completed after snaring the tip and ballooning the treated area.No further patient injury reported.
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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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Manufacturer Narrative
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Medwatch report received report number: (b)(4).Additional information received: the tip was snared into the sheath and then pull the tip out of the sheath by removing the spider fx device from the patient.The tip of the hawkone was intact upon removal.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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