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

Model Number FG13160-0615-1S

Device Problems Compatibility Problem (2960); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/21/2021

Event Type  malfunction  

Manufacturer Narrative

Product analysis: as found condition: the phenom-21 micro catheter was returned for analysis within a shipping box; within two resealable plastic biohazard pouches.The unknown stent retriever and solitaire platinum used in the event was not returned for analysis.Visual inspection/damage location details: no damages were found with the phenom-21 micro catheter hub.No damages or irregularities were found with the external catheter body, distal tip, or marker band.Testing/analysis: the phenom-21 micro catheter total length was measured to be ~168.6cm and the usable length was measured to be ~162.1cm, which is within specification (specification: total (ref) = 166.5cm, usable: 160cm ± 5cm).The micro catheter was flushed with water, and water was found to exit the distal end.An in-house guidewire was inserted into the phenom-21 micro catheter hub, through the catheter and out the distal end with light resistance encountered.A long strip of knotted up inner wire was pushed out of the micro catheter.Conclusion: based on the device analysis and reported information, the customer¿s report of ¿catheter resistance¿ and ¿catheter occlusion¿ was confirmed.The cause of the resistance/occlusion is due to the damaged liner.The cause of the damage could not be determined.There was no reported resistance or occlusion during the first passthrough, therefore it is possible the damage occurred when advancing the stent retriever during the second pass against the reported resistance.As the stent retriever and solitaire platinum used in the event was not returned for analysis, any contribution of the devices towards resistance could not be determined.There was no indication that the event was related to a potential manufacturing issue.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 Description

Medtronic received a report that there was resistance with the catheter.The patient was undergoing surgery for thrombectomy treatment for right ic (internal carotid) artery occlusion.The access vessel was the right ic with a diameter of 4.5mm.It was noted the patient's vessel tortuosity was moderate.It was reported that this applicable product was used in the another company suction catheter to approach the lesion.1 pass was performed using another company's stent retriever.It was still occluded, so it approached the lesion part again.Attempts were made to insert another company's stent retriever, which was used for the first pass, but it stuck on the proximal side of the catheter and could not be inserted.There was catheter resistance in the shaft proximal section.They tried to use our company's solitaire platinum 6 mm, but it stuck at the same location.It was replaced with a microcatheter from another company; when another company's stent retriever was inserted earlier, it could be inserted without any problems, the procedure was continued and completed.No patient symptoms or further complications were reported as a result of this event.The device was prepared as indicated in the package insert.The catheter was flushed as indicated in the ifu.

• 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: 13831008
• MDR Text Key: 297521600
• Report Number: 2029214-2022-00441
• 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
• Report Date: 03/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FG13160-0615-1S
• Device Catalogue Number: FG13160-0615-1S
• Device Lot Number: 222091108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2022
• Date Device Manufactured: 04/21/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Sex: Male