MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 SUPPORT GUIDECATHETER; CATHETER, PERCUTANEOUS

Model Number	RFX058-115-08
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report that the navien catheter ruptured during use.The patient was undergoing pipeline placement.The accessed vessel was the left groin with a vessel diameter of 3 mm.It was noted the patient's vessel tortuosity was moderate.It was reported that catheter rupture occurred.It was reported the catheter was broken.The ruptured location was the distal section.There was no friction or difficulty during delivery.Aside from the rupture there was no other damage to the catheter.The injection rate is unknown.It was noted the doctor had no tower of power and he went bare back with the navien catheter.The navien frayed the inner liner in the body.The doctor was able to pull it out, but he only had short 6f groin sheath in.No intermediate as had to take benchmark out and ended up having to hold pressure on right groin and accessed left.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).The catheter was flushed as indicated in the ifu.Additional information was received that the lesion was located in the cavernous internal carotid artery and was large.The catheter did not fracture into multiple pieces.The distal part of the catheter was fractured.The in nitinol coil unraveled but was still connected to the very distal tip.It was not believed that there were any catheter pieces left in the patient.The patient did not experience any additional symptoms related to the catheter break.The cause of the catheter break was thought to be due to the hcp not having a tower of support, nothing but a short sheath in groin in.
Additional Manufacturer Narrative
Product analysis of rfx058-115-08, lot no:b531022 ¿ damage location details: dried blood was found within the navien catheter hub.The navien catheter was found separated at ~104.5cm from the proximal end of the catheter hub (~19.2cm from the distal tip), retained by the inner wire.The tubing material at the catheter separated ends exhibited plastic deformation (jagged edges).The navien catheter inner wire was found extending out from within the 6fr sheath hub and distal tip.The 6fr sheath distal tip was found damaged (indented).The navien catheter distal tip was found in good condition.¿ conclusion: based on the device analysis and reported information, the customer¿s ¿catheter separation/break¿ report was confirmed.Possible causes of ¿catheter separation/break¿ include user operational context if user advances or retrieves the device against resistance, vasospasm, patient vessel tortuosity, or user applies excessive force, thus exceeding tensile strength of tubing material.However, the cause for the catheter separation could not be determined.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.

• Brand Name: SUPPORT GUIDECATHETER
• Common Device Name: CATHETER, PERCUTANEOUS
• 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: 17072446
• Report Number: 2029214-2023-00889
• Device Sequence Number: 6129711
• Product Code: DQY
• UDI-Device Identifier: 00847536017795
• UDI-Public: 00847536017795
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K110055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/10/2025
• Device Model Number: RFX058-115-08
• Device Catalogue Number: RFX058-115-08
• Device Lot Number: B531022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2023
• Supplement Date Received by Manufacturer: 07/11/2023
• Initial Report FDA Received Date: 06/06/2023
• Supplement Report FDA Received Date: 08/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Sex: Male