MAUDE Adverse Event Report: COOK INC; DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Encephalopathy (1833); Paresis (1998); Visual Impairment (2138); Convulsion/Seizure (4406); Speech Disorder (4415); Ischemia Stroke (4418)

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

As published in the literature (mellemkjaer et al., 2021), a 25-year-old female patient underwent a procedure involving elective endovascular coiling of an unruptured aneurysm in the left internal carotid artery, under general anesthesia and with single groin access, during which an unspecified cook 4-french vertebral catheter was used.The procedure was complicated by severe vasospasms in the supra-clinoidal segment of the left internal carotid artery, which was treated with one milligram of intra-arterial nimotop.The day following the procedure, the patient woke with aphasia, right hemiparesis and hemianopsia.The patient was admitted to the stroke unit with a nihss (national institute of health stroke scale) score of seven.Magnetic resonance imaging (mri) found acute punctuate cortical infarctions and small cortical areas of diffusion restriction in the left hemisphere in an embolic pattern.Thrombolytics were administered intravenously with some effect.The nihss score was four after 24-hours, and the patient was discharged to rehabilitation.Nine weeks later, the patient was readmitted after having a tonic-clonic seizure.Blood and cerebrospinal fluid tests were normal; however, mri noted diffuse hyperdensity and vasogenic edema with a slight mass effect of the left cerebral hemisphere.The patient was started on lamotrigine and later switched to levetiracetam for prevention of seizures.One hundred milligrams of oral prednisolone was given daily.The patient had a recurrence of headaches when a rapid steroid taper was attempted; therefore, the dose was increased when the patient developed headaches and was then carefully tapered and discontinued over nine months.Although the patient¿s symptoms improved, she continues to have simple partial seizures and remains on levetiracetam.The authors note that the patient was young and had no signs of atherosclerosis.Because the patient developed acute cortical infarctions immediately after the coiling procedure and presented with symptoms of delayed leukoencephalopathy at the same site as the infarction nine weeks later, the authors believe the findings to be a strong indicator of an inflammatory reaction caused by polymer embolization.There has been no alleged malfunction of the cook catheter.Other manufacturers¿ sheaths, catheters, balloons, and coils were 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/.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Summary of event: as published in the literature (mellemkjaer et al., 2021), a 25-year-old female patient underwent a procedure involving elective endovascular coiling of an unruptured aneurysm in the left internal carotid artery, under general anesthesia and with single groin access, during which an unspecified cook 4-french vertebral catheter was used.The procedure was complicated by severe vasospasms in the supra-clinoidal segment of the left internal carotid artery, which was treated with one milligram of intra-arterial nimotop.The day following the procedure, the patient woke with aphasia, right hemiparesis and hemianopsia.The patient was admitted to the stroke unit with a nihss (national institute of health stroke scale) score of seven.Magnetic resonance imaging (mri) found acute punctuate cortical infarctions and small cortical areas of diffusion restriction in the left hemisphere in an embolic pattern.Thrombolytics were administered intravenously with some effect.The nihss score was four after 24-hours, and the patient was discharged to rehabilitation.Nine weeks later, the patient was readmitted after having a tonic-clonic seizure.Blood and cerebrospinal fluid tests were normal; however, mri noted diffuse hyperdensity and vasogenic edema with a slight mass effect of the left cerebral hemisphere.The patient was started on lamotrigine and later switched to levetiracetam for prevention of seizures.One hundred milligrams of oral prednisolone was given daily.The patient had a recurrence of headaches when a rapid steroid taper was attempted; therefore, the dose was increased when the patient developed headaches and was then carefully tapered and discontinued over nine months.Although the patient¿s symptoms improved, she continues to have simple partial seizures and remains on levetiracetam.The authors note that the patient was young and had no signs of atherosclerosis.Because the patient developed acute cortical infarctions immediately after the coiling procedure and presented with symptoms of delayed leukoencephalopathy at the same site as the infarction nine weeks later, the authors believe the findings to be a strong indicator of an inflammatory reaction caused by polymer embolization.There has been no alleged malfunction of the cook catheter.Other manufacturers¿ sheaths, catheters, balloons, and coils were 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.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, various other devices were also used during the procedure.Because it is documented in the literature that leukoencephalopathy can be caused by contrast, a hypersensitivity reaction to coil material, and embolization of hydrophilic coating, cook has concluded that it is possible that procedural issues and/or the body¿s response to the procedure and/or devices possibly contributed to this event.It is also possible that in this case, the embolic stroke was caused by thrombus, which explains why thrombolytics were somewhat effective in treating symptoms, and that the symptoms of leukoencephalopathy and seizures were the result of the stroke; 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.

• Type of Device: DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 17499489
• MDR Text Key: 320904236
• Report Number: 1820334-2023-01061
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: DA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 017 HEADWAY DUO MICROCATHETER (MICROVENTION).; 021 PROWLERSELECT PLUS (CODMAN).; 4×10 MM TRANSFORM SUPERCOMPLIANT BALLOON (STRYKER).; 6F FARGOMAX GUIDING CATHETER (BALT).; 6F SHEATH (IVA, BALT).; TRUFILL PLATINUMCOILS (CODMAN).
• Patient Outcome(s): Required Intervention; Other; Hospitalization
• Patient Age: 25 YR
• Patient Sex: Female