MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 CATHERA; CATHETER, CONTINUOUS FLUSH

Model Number FG15150-0615-1S

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

Patient Problems Granuloma (1876); Dysphasia (2195); Confusion/ Disorientation (2553)

Event Date 04/08/2024

Event Type  Injury  

Event Description

Medtronic received information that up until around march 22, daily life (single living) was confirmed; starting from march 23, the patient had an epileptic seizure and could not operate the smartphone (according to the patient).On march 27, the message on line was not read (usually the message was read immediately). on march 28, the family member (living separately) visited the patient for a scheduled visit to the department and found the patient lying next to the bed in an incontinent state. eyes opening to call, no upper extremity paralysis, no aphasia, there is dysarthria, there is disorientation, but the patient is semi-awake 140/100. mri/mra no acute stent occlusion, there is left frontal/parietal lobe flair high/dwi negative cortical lesion, and there is left temporal lobe medial left thalamus medial flair high/dwi negative cortical lesion. mri findings strongly suggest that foreign-body granuloma is the primary cause and that symptomatic epilepsy due to it is strongly suspected, and that thromboembolism should also be investigated (although it is a sufficient condition to be suspected). increasing the diagnostic accuracy and differentiating diagnosis require contrast mri and dsa, however, it was determined that it would be desirable after improvement in renal function; transfusion-loaded steroid (rinderon 2mg) antiepileptic (levetiracetam 250mg x 2/day) antithrombotic (argatroban 40mg/day bayaspirin 100mg clopidogrel 75 mg) antibiotics (cefamezin) initiated.2024-apr-12 ared (rep, hcp, for): additional information received reported from the mri findings, foreign body granulomatosis is the main cause, and symptomatic epilepsy due to it is strongly suspected.

Manufacturer Narrative

Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Manufacturer Narrative

Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: CATHERA
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 19193607
• MDR Text Key: 341172058
• Report Number: 2029214-2024-00769
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K151638
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: FG15150-0615-1S
• Device Catalogue Number: FG15150-0615-1S
• Device Lot Number: 227567176
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/08/2024
• Initial Date FDA Received: 04/26/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/31/2024
• Date Device Manufactured: 10/20/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female