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

Model Number FA-55160-1030

Device Problems Deformation Due to Compressive Stress (2889); Physical Resistance/Sticking (4012)

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

Event Type  malfunction  

Manufacturer Narrative

The marksman micro catheter was returned for analysis.Four segments of the distal marksman micro catheter were returned.The non-medtronic stent retriever (j&j medical embotrap) used in the event was not returned for analysis.No flash or hub mold were found within the hub.No damages or irregularities were found with the marksman hub.The first cut on the marksman micro catheter was found at ~138.5cm from the proximal end.Multiple breaks and cuts were observed along the length of the distal micro catheter as 4 other segments were returned.The distal tip and marker band was not returned for analysis.The marksman total length and usable lengths could not be measured.The proximal inner diameter was measured to be 0.027¿, which is within specification (specification: 0.027¿ ± 0.001¿).The distal inner diameter could not be measured.An in-house 0.0265¿ mandrel was inserted through the marksman catheter hub, and resistance was encountered at the accordioned section.Based on the device analysis and reported information, the customer report of ¿catheter resistance¿ was confirmed; however, the cause could not be determined.Possible causes for resistance are patient vessel tortuosity, insufficient continuous flush, insufficient device hydration, catheter/delivery system/stent retriever damage or material occludes catheter.The customer report of ¿catheter accordion¿ was confirmed.It is likely the accordioning occurred due to retracting the stent retriever against the reported resistance.Other possible causes are stent retriever removed aggressively or catheter entrapment.Customer reported all devices were prepared/flushed per ifu and the manufacturer of the embotrap reported cutting the marksman micro catheter to extract and analyze the stent retriever.As the j&j medical embotrap used in the event was not returned for analysis, any contribution of the embotrap towards the resistance could not be assessed.The embotrap is rated to be used with micro catheters with an inner diameter of 0.021¿ ¿ 0.027¿ (per j&j medical website).Therefore, the embotrap is compatible for use with the marksman micro catheter.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 information regarding a marksman catheter that had resistance with a non-medtronic stent retriever and became damaged.It was reported that the patient was undergoing a large vessel mechanical thrombectomy procedure to treat stroke.The marksman catheter and all accessory devices were prepared according to the instructions for use (ifu).The catheter was flushed per ifu.During the procedure the non-medtronic stent retriever became stuck in the marksman microcatheter causing the catheter to accordion throughout.The devices were removed from the patient.  no patient symptoms or complications were reported.The devices were sent to the competitor and the competitor noted that the marksman catheter had to be cut to remove the stent.No damages were seen with marksman lining but accordion damage was seen throughout.

• Brand Name: MARKSMAN
• 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: 14017677
• MDR Text Key: 298312033
• Report Number: 2029214-2022-00580
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 04/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FA-55160-1030
• Device Catalogue Number: FA-55160-1030
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1