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

Model Number	FA-55150-1030
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The pipeline flex pusher was found protruding from within the marksman catheter hub for ~17.8cm.No damage was found with the marksman catheter hub.The marksman catheter was found stretched and separated on the pipeline flex pusher at ~130.3cm from the proximal end of the hub.The tubing material of the separated ends exhibited with stretching, necking and jagged edges with the inner braid exposed.The pipeline flex braid was found partially deployed from within the marksman distal tip.The pipeline flex braid distal end was found open, but damaged (frayed).The ptfe sleeves and tip coil were found in good condition.The pipeline flex embolization device was pushed out from within the phenom 27 catheter with resistance, causing the braid to fully deploy.The pipeline flex pusher, proximal bumper, resheathing pad and resheathing marker were found intact.The pipeline flex braid proximal end was found open, but damaged (frayed).No other anomalies were observed.Based on the device analysis and reported information, the customer¿s report of ¿failure/incomplete open¿ could not be confirmed, as the device has been fully deployed and re-sheathed.Possible causes for failure to open are patient vessel tortuosity, damaged braid, braid improperly sized to anatomy, braid was overstretched during delivery, user deploys braid in vessel bend, presence of other indwelling endovascular stents, or inappropriate anatomy.It is likely the damage found with the braid (fraying) and the patient¿s ¿severe¿ vessel tortuosity contributed to the event; however, the root cause could not be determined.Regarding the customer¿s report of ¿resistance/stuck during delivery¿ the issue was confirmed.From the damages seen with the marksman catheter (stretch, separation); it appears there was high force used.The broken ends of the catheter exhibited with plastic deformation (jagged edges and stretching) which indicated that the catheter separated when exceeding the tensile strength of the tubing material.It is likely these damages occurred when the customer attempted to advance and/or retrieve the pipeline flex through the marksman catheter against resistance subsequently causing the catheter to become separated.Based on the investigation conducted resistance can occur during tracking, deployment and re-sheathing of the device in distal and tortuous anatomies.In addition, resistance can occur due to failure to maintain a continuous flush or pipeline is pulled back/torqued during delivery.It is likely the patient¿s ¿severe¿ vessel tortuosity contributed to the resistance; however, the root cause for the reported resistance could not be determined.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report that the pipeline could not be delivered through the marksman, and the distal segment failed to open.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm of the right posterior communicating (pcom) artery with a max diameter of 4 mm and a 3 mm neck diameter.It was noted the patient's vesseltortuosity was severe.Dual antiplatelet therapy (dapt) was administered: prasugrel.It was reported that the marksman microcatheter was positioned in sector m1/m2, and an attempt was made to deploy the pipeline.However, force was exerted, but it was not possible to advance the pipeline.The stent did not come out of the marksman, and the entire set was removed.It was also stated the distal segment of the pipeline failed to open.The stent was not positioned in a bend, less than 50% was deployed, and resheathing was performed less than three times.A replacement pipeline was used to complete the procedure.It was indicated that all devices were prepared as per the instructions for use (ifu), and no patient symptoms or further complications were reported as a result of this event.Post-procedure angiography showed satisfactory results.Additional information received reported that the pipeline got stuck and couldn't be released.It was unknown if there was any damage to the catheter or pipeline.

• Brand Name: MARKSMAN
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 11047997
• Report Number: 2029214-2020-01354
• Device Sequence Number: 1087899
• Product Code: KRA
• UDI-Device Identifier: 00836462014077
• UDI-Public: 00836462014077
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• PMA/510(K) Number: K091559
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/21/2020

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: 08/27/2022
• Device Model Number: FA-55150-1030
• Device Catalogue Number: FA-55150-1030
• Device Lot Number: 218342883
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2020
• Initial Report FDA Received Date: 12/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 65