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

Model Number	RFX058-125-08
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: product analysis #705560754:equipment used: video inspection system (m-81805), ruler (m-83360) camera (panasonic lumix dmc-zs5); in-house 0.051¿ mandrel, drawing(s) referenced: dwgsrfx058-125-08 rev.N as found condition: the navien intracranial support catheter was returned for analysis within a shipping box and within a sealed plastic biohazard pouch.The unknown guidewire used during the event was not returned for analysis.Visual inspection/damage location details: no damages were found with the navien hub.Dried blood was found within the hub.No damages or irregularities were found with the external catheter body.The distal tip and marker band was found flattened.The inner liner was found delaminated at the tip.Testing/analysis: the navien useable length was measured to be ~112.5cm which is not within specification (specification for rfx-058-125-08 is 125cm ± 3cm).The usable length measurement suggests that the navien catheter returned is model # rfx058-115-08 (specification: 115cm ± 3cm).It is unclear if the correct navien catheter was returned.The inner diameter of the hub was measured to be 0.0575¿ which is within specification.The inner diameter of the distal tip could not be measured due to the damage.The navien catheter was flushed, and water was found to exit the tip.An in-house 0.051¿ mandrel was inserted through the navien catheter hub, through the catheter body and became stuck at ~23.2cm from the proximal end.The catheter was cut, and the inner liner was found damaged and delaminated at the location of resistance.Conclusion: based on the device analysis and reported information, the customer¿s report of ¿catheter resistance¿ was confirmed.The cause of the resistance was found to be the liner damaged/delaminated liner.However, the cause of the liner damage could not be determined.Possible causes for catheter tip flattening are patient vessel tortuosity or user advances/retrieves intraluminal device against resistance.As the unknown guidewire used in the event was not returned for analysis, any contribution of the guidewire towards the resistance or catheter damage could not be determined.As the model and lot numbers were not reported, compatibility could not be assessed.Customer reported that the guidewire tip was found slightly deformed, which could have contributed towards the resistance.There is an indication that the failure is related to a potential manufacturing issue, therefore a dhr review will be performed.Ngod10 2023-05-19 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.
Event or Problem Description
Additional information received reported that the micro-guide wire never came out, there was resistance.The guidewire was able to pass the catheter hub.There was no damage found to the catheter hub.The guidewire tip was slightly deformed.There was no kink/damaged found on the guidewire.

• 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: 16976492
• Report Number: 2029214-2023-00828
• Device Sequence Number: 11398702
• Product Code: DQY
• UDI-Device Identifier: 00847536017849
• UDI-Public: 00847536017849
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/20/2023
• Device Model Number: RFX058-125-08
• Device Catalogue Number: RFX058-125-08
• Device Lot Number: B301928
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2023
• Initial Report FDA Received Date: 05/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2021
• 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 Sex: Male