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

Model Number FA-55150-1030

Device Problems Difficult or Delayed Activation (2577); Device Dislodged or Dislocated (2923)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/27/2019

Event Type  malfunction  

Manufacturer Narrative

The device has been received and device evaluation anticipated, but not yet begun.Upon completion of the device evaluation a supplemental report will be filed.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that marker band dislodged from the catheter.The patient underwent thrombectomy treatment for cerebral thrombosis collection treatment.The vessel was observed severely tortuous.It was reported that regarding the occlusion beyond the left a2, when marksman was delivered using chikai 14 guidewire, the tortuosity was considerably severe, and arteriosclerosis was also observed.Therefore, the marksman was pushed forward as it was although strong resistance was felt.After that, when the marksman catheter was removed, it was confirmed that the marker at the tip was disengaged and the marker was in the distal part of the left a2.The device prepared according to the instructions per the ifu.The catheter was hydrated per the ifu.There were not any additional surgical or medical actions performed.It is unknown about the patient current medical condition but there was no complications or symptoms associated with the event.There was not any treatment plan for that metal piece remains in the patient.The thrombus could not be collected and the procedure was completed.

Manufacturer Narrative

D10: device available for evaluation - additional information g4.Date mfr rec ¿ additional information h2: type of follow up - device evaluation h3: device evaluated by manufacturer- additional information h6: codes updated the device was returned for evaluation and the clinical observation was confirmed.As received, no damages or irregularities were found with the marksman hub.The distal of the marksman catheter body was found flattened.Approximately 2mm of the marksman distal marker band/tip was found dislodged from the catheter.The dislodged marksman marker band/tip will not be returned as it remains within the patient.The separated outer tubing material exhibited with plastic deformation (jagged edges and stretching).There does not appear to be any separation of the inner liner.The marksman catheter was flushed, water exited from the distal tip.No other anomalies were observed.Based on the device analysis and reported information, it is likely that the patient¿s ¿severe¿ vessel tortuosity contributed to the reported difficulty during navigation and separation of the marksman marker band.The separated outer tubing material exhibited with plastic deformation which indicates the marker band dislodged as the tensile strength of the tubing material was exceeded.In addition, as the marksman was found flattened it is likely that the guide catheter was kinked/damaged causing the marksman to flatten if pulled through likely against resistance.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: MARKSMAN CATHETER
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 9310462
• MDR Text Key: 195111610
• Report Number: 2029214-2019-01122
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• PMA/PMN Number: K091559
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/15/2020

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
• Device Operator: Health Professional
• Device Model Number: FA-55150-1030
• Device Lot Number: 217599579
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2019
• Initial Date Manufacturer Received: 10/28/2019
• Initial Date FDA Received: 11/12/2019
• Supplement Dates Manufacturer Received: 01/03/2020
• Supplement Dates FDA Received: 01/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other