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Catalog Number UNKNOWN |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Encephalopathy (1833); Headache (1880); Inflammation (1932); Nausea (1970); Dizziness (2194)
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Event Type
Injury
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Event Description
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As published in the literature (mellemkjaer et al., 2021), a 21-year-old male was admitted for a cerebellar hemorrhage and treated conservatively with placement of an external drain for seven days.An uncomplicated conventional diagnostic arteriogram, performed under local anesthesia and using another manufacturer¿s sheath and an unspecified cook 4-french vertebral catheter, was normal.Eight weeks later, the patient developed delayed leukoencephalopathy and was readmitted for progressive headaches, nausea, and dizziness.Magnetic resonance imaging showed hyperdensity in the left cerebellar and both cerebral hemispheres with multiple contrast-enhancing lesions supratentorially and infratentorially.Blood tests were normal; however, testing of the cerebrospinal fluid (csf) noted inflammation, a mononuclear white blood cell count of 94 l, protein of 0.65 g/l, and positive immunoglobulin igg index of 0.89.The csf was negative for lyme and viral disease.A lymphoma screen was negative, and a computed tomography (ct) can of the abdomen, pelvis, and thorax was normal.The patient was treated with 100-milligrams of oral prednisolone daily.The dose was tapered over five months, and the patient made a good recovery.There has been no alleged malfunction of the cook catheter.Another manufacturer¿s sheath was also used during the procedure.Reference for article: mellemkjær t, chandra rv, speiser l, ulhøi bp, simonsen cz.Delayed leukoencephalopathy from suspected polymer embolism after neuroendovascular procedures.The neuroradiology journal.2021 aug;34(4):373-378.Doi: 10.1177/19714009211029172.Retrieved from: https://www.Ncbi.Nlm.Nih.Gov/pmc/articles/pmc8447825/.
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Manufacturer Narrative
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D4: based on the product description of a cook 4 french "vertebralis" catheter, possible rpns include: hnbr4.0-35-100-p-ns-vert, hnbr4.0-35-170-p-ns-vert, hnbr4.0-35-125-p-ns-vert, hnbr4.0-35-150-p-ns-vert, hnbr4.1-35-100-p-ns-vert, scbr4.0-38-100-p-ns-vert, scbr4.0-38-125-p-ns-vert, scbr4.0-38-65-p-ns-vert.E1: customer name and address= address line 2: (b)(6).G4: pma/510(k) number = unavailable as the device lot number, rpn, and gpn are unknown.Possible 510(k)s are: k133130, k122937, or pre-amendment.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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Event Description
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No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
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Manufacturer Narrative
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Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Summary of event: as published in the literature (mellemkjaer et al., 2021), a 21-year-old male was admitted for a cerebellar hemorrhage and treated conservatively with placement of an external drain for seven days.An uncomplicated conventional diagnostic arteriogram, performed under local anesthesia and using another manufacturer¿s sheath and an unspecified cook 4-french vertebral catheter, was normal.Eight weeks later, the patient developed delayed leukoencephalopathy and was readmitted for progressive headaches, nausea, and dizziness.Magnetic resonance imaging showed hyperdensity in the left cerebellar and both cerebral hemispheres with multiple contrast-enhancing lesions supratentorially and infratentorially.Blood tests were normal; however, testing of the cerebrospinal fluid (csf) noted inflammation, a mononuclear white blood cell count of 94 ¿l, protein of 0.65 g/l, and positive immunoglobulin igg index of 0.89.The csf was negative for lyme and viral disease.A lymphoma screen was negative, and a computed tomography (ct) can of the abdomen, pelvis, and thorax was normal.The patient was treated with 100-milligrams of oral prednisolone daily.The dose was tapered over five months, and the patient made a good recovery.There has been no alleged malfunction of the cook catheter.Another manufacturer¿s sheath was also used during the procedure.Reference for article: mellemkjær t, chandra rv, speiser l, ulhøi bp, simonsen cz.Delayed leukoencephalopathy from suspected polymer embolism after neuroendovascular procedures.The neuroradiology journal.2021 aug;34(4):373-378.Doi: 10.1177/19714009211029172.Retrieved from: https://www.Ncbi.Nlm.Nih.Gov/pmc/articles/pmc8447825/ investigation evaluation: reviews of the instructions for use (ifu) and quality control procedures were conducted during the investigation.The complaint device was not returned to cook for investigation.The lot number was not provided to cook; therefore, the device history record and complaint history could not be reviewed.The product ifu states ¿do not use the product if there is doubt as to whether the product is sterile.¿ the information provided upon review of the dmr, ifu, and journal article suggests that there is evidence the device was manufactured to specification.There is no evidence of non-conforming devices in-house or in the field.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify potentially related non-conformances prior to distribution.Based on current information, cook was unable to establish a definitive cause for this event.There was no alleged malfunction or specific evidence of coating embolization of the cook device in this case.Per the information in the literature article, another manufacturer¿s sheath was also used during the procedure.Because it is documented in the literature that leukoencephalopathy can be caused by contrast and embolization of hydrophilic coating, it is possible that embolization of hydrophilic coating may have caused this event; however, there was no alleged malfunction or catheter damage.In this case, it is also possible that the symptoms of delayed leukoencephalopathy could be associated with inflammation or infection caused by the external drain that was in place for even days; however, this cannot be confirmed based on current information.The risk analysis was reviewed, and no additional escalation was required.The appropriate personnel have been notified and cook will continue to monitor for similar events.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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Search Alerts/Recalls
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