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Device Problem
Detachment of Device or Device Component (2907)
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Patient Problems
Pain (1994); Anxiety (2328); Insufficient Information (4580)
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Event Date 06/19/2020 |
Event Type
Injury
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Event Description
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A physician performed a procedure on patient using the hawkone atherectomy device to remove an obstruction in the right leg.The procedure included the entry into the vein of the device used to clean the residue in vein after breaking the calcification that created the obstruction.It was reported that at the time of using the device to clean the vein it broke leaving a metallic device(wire) in the groin area of the patient.The specialist physician in cardiac vascular surgery was unavailable until the next day to complete the intervention required to remove the detached wire so patient was admitted to spend the night in hospital.It was reported that the patient was anguished by the fact that he had a piece of metal in his body and had to spend the night without moving, since this would put him at risk.The physician and nurses informed that patient they had spend the next few hours without being able to move, since it would put his medical condition and/or even his life at risk.The next day the patient reported that he had cramps in his leg, which caused him a lot of pain and anguish.The physician explained that he had to open the groin and open the vein to be able to remove the piece of metal and that the patient would have a stitch in the vein and an open wound in the groin that would heal with the passage of time.The next day the patient was discharged from the hospital with the instruction of wound maintenance and future appointments with the physician.It was reported that the patient had suffered mental anguish and physical damage such as pain in his leg, fear of dying and mental anguish due to the uncertainty of not knowing what would happen and the negligent medical attention he received.
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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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Additional information: unknown if pre-deployed stent present when performed atherectomy.Unknown if the retained metal (wire) was a fragmented guidewire or part of the hawkone 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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Search Alerts/Recalls
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