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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 03/25/2019 |
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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The physician was using a 6fr hawkone to treat a severely calcified lesion in the right proximal superficial femoral artery (sfa) and popliteal artery.Artery diameter is 5-6mm and severely tortuous.A non medtronic 7fr sheath and a non medtronic 5mm embolic protection device was used in the procedure.The vessel was pre-dilated.The ifu was followed.It was reported that some difficulty was encountered while advancing the initial wire through the right iliac arteries, but the sheath did advance with little resistance.The device functioned as planned during multiple cuts and passes.The physician rotated the device on several occasions freely but ultimately in one direction only.During removal of the device from the popliteal artery, no resistance was encountered.Eventually some resistance was noted and the physician was instructed to stop withdrawal and visualize under fluoroscopy.At this time, the wire was noted to be prolapsed prior to entry into the sheath.The physician attempted to unwrap and free the wire.Attempts were unsuccessful due to a hard kink in the wire.At this point the nose cone detached from the shaft of the hawk device at the hinge pin.There was no excessive force used by the physician.Physician was unable to pass a catheter over the kink in the wire, or pull the wire and detached tip into the sheath.During these attempts the filter wire broke and separated into two pieces.The free portion of the wire was removed.A gooseneck snare was use in attempt to snare the hawk nose cone, followed by several attempts of the remaining wire.After the failed attempts, a non medtronic snare was used to capture the nose cone and pulled to the tip of the sheath.Both the sheath and nose cone were removed simultaneously, while leaving the distal portion of the wire and filter inside the patient.The exposed wire was cut by the tip of the hawk nose cone.A new 7 fr sheath was advanced using the.018" dilator, and the filter was retrieved.Manual pressure was held to obtain hemostasis.Patient experienced hypotension at the time of the tip detachment and may have required blood products due in part to defective non medtronic sheath hub.This event was addressed but reoccurred during the sheath removal.Due to the original sheath malfunction, labs were drawn for potential blood transfusion.The final sheath was removed to aid in removal of the filter and wire, so no final angiograms were completed at the time of the procedure.
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Manufacturer Narrative
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Additional information: the patient was monitored overnight in the icu and discharged home the following day.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Cine review: the customer provided a cine image from the procedure.Upon review of the cine the housing assembly appears to be disengaged distal to the tip of the introducer sheath.It could not be determined where the separation/suspected fracture occurred from the image provided.The cine image was able to identify components within the vessel, but the clarity of the cine could not specifically identify the nature of the separation.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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