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

Catalog Number UNKNOWN

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

Patient Problems Encephalopathy (1833); Inflammation (1932); Paresis (1998); Movement Disorder (4412); Speech Disorder (4415)

Event Type  Injury  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.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), postal: (b)(6), street:(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 69-year-old female patient underwent a procedure involving coiling and balloon remodeling of a non-ruptured right pericallosal aneurysm under general anesthesia and with single groin access, during which an unspecified cook 4-french vertebral catheter was used.The procedure was prolonged (four hours and fourteen minutes) due to difficult superselective double-catheterization of the pericallosal artery.A ¿significant¿ amount of iodine was used during the procedure.Four weeks later, the patient was re-admitted with left hemiparesis, ataxia, and dysarthria, which had progressed over one week.Cerebrospinal fluid and blood tests were normal.Magnetic resonance imaging (mri) noted multiple contrast-enhanced lesions, located mostly in the right hemisphere, and vasogenic edema in the watershed areas.A malignancy was suspected, and a biopsy was performed, which found non-specific reactive changes with granulomatous inflammation.The patient was treated with 96-milligrams of methylprednisolone daily, tapered over two months.The patient experienced full remission of symptoms.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

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 69-year-old female patient underwent a procedure involving coiling and balloon remodeling of a non-ruptured right pericallosal aneurysm under general anesthesia and with single groin access, during which an unspecified cook 4-french vertebral catheter was used.The procedure was prolonged (four hours and fourteen minutes) due to difficult superselective double-catheterization of the pericallosal artery.A ¿significant¿ amount of iodine was used during the procedure.Four weeks later, the patient was re-admitted with left hemiparesis, ataxia, and dysarthria, which had progressed over one week.Cerebrospinal fluid and blood tests were normal.Magnetic resonance imaging (mri) noted multiple contrast-enhanced lesions, located mostly in the right hemisphere, and vasogenic edema in the watershed areas.A malignancy was suspected, and a biopsy was performed, which found non-specific reactive changes with granulomatous inflammation.The patient was treated with 96-milligrams of methylprednisolone daily, tapered over two months.The patient experienced full remission of symptoms.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: (b)(4) 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, it was noted that a ¿significant¿ amount of iodine was used during the procedure, multiple other medical devices (possibly hydrophilically coated) were used, and an embolization coil was placed.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.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.

• Brand Name: UNKNOWN
• 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: 17498888
• MDR Text Key: 320791341
• Report Number: 1820334-2023-01060
• 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,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/05/2023

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 SL-10 MICROCATHETERS [STRYKER]; 6F ENVOY GUIDING CATHETER [CODMAN]; 6F SHEATH [IVA, BALT]; COPERNIC BALLOON [BALT]; TRUFILL PLATINUM COILS [CODMAN]
• Patient Outcome(s): Other; Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female