Catalog Number H1-M-INT |
Device Problems
Entrapment of Device (1212); Detachment of Device or Device Component (2907); Difficult to Advance (2920)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/08/2019 |
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 used a hawkone directional atherectomy along with 6 mm spider fx embolic protection to treat a severely calcified lesion in the right mid sfa with 90% stenosis.The vessel is severely tortuous.The vessel diameter and lesion length are 5 mm and 3 mm respectively.The vessel was not pre or post dilated.Ifu was followed during preparation, procedure and post procedure.It was reported that during withdrawal, moderate resistance was felt.During attempt to withdraw devices post procedure, the spider wire created a loop around the hawkone device, while trying to remove from patient, it broke into pieces.There was no alleged product issue reported for spider fx.
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Manufacturer Narrative
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Additional information: a 6fr non-medtronic sheath was used in this procedure.The broken components were pushed up to the tip of the sheath and were re moved together with the sheath with a wire in place.The tip did not separate at hinge pins.All device fragments were removed from the patient.If information is provided in the future, a supplemental report will be issued.
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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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Product analysis: the hawkone device was returned connected to a cutter driver.The fractured off distal assembly was placed inside a separate individual pouch with a portion of the capture wire loaded.The hawkone was fractured apart at the distal assembly.The radial fracture occurred at the proximal area of where the coil segment of the housing starts and distal to the anchor pockets.The distal segment placed inside its own pouch was inspected.A portion of a suspected capture wire from the spider fx was loaded the guidewire lumen of the rotating tip.The capture wire appeared as though it was cut by a sharp instrument.The ptfe coating of the wire was scraped off due to likely experienced friction.The filter assembly portion was not included.The wire was bent/coiled.The distal segment of the hawkone showed the guidewire lumen exhibited a zipper tear.The guidewire lumen of the rotating tip was intact but was protruding outward at the proximal end of the segment.The proximal segment of the hawkone showed a radial fracture face of the housing.The drive shaft was exposed outside of the cutter window with the cutter assembly attached.Image review: the customer provided two photos of the hawkone post-procedure and one cine image.The photos of the hawkone show the distal assembly of the hawkone fractured apart with a portion of the capture wire loaded the rotating tip.The fracture occurred at the proximal edge of the coiled segment, distal the anchor pockets the cine provided was inconclusive regarding specific locations of the fracturing.The distal assembly of the hawkone was identified as well as the ro horseshoe of the deployed filter.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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