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

Model Number FA-55150-1030

Device Problem Material Puncture/Hole (1504)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/23/2019

Event Type  malfunction  

Manufacturer Narrative

As the device was received in a condition was contradictory to the complaint description.Returned device found that the pipeline flex pushwire was found broken.Also the catheter body it was found under the vis what appeared to be a wire protruding from the catheter body.This condition was not reported during time of the event.As received, the pipeline flex embolization device and marksman catheter were returned for analysis.The distal hypotube was found to be stretched and ptfe shrink tubing was found to be pulled back ~0.9mm with no signs of elongation.The proximal bumper and re-sheathing marker were found to be intact.The re-sheathing pad appeared to be good condition.The tip coil, braid and distal dps restraints were found to be missing.The pushwire was found broken.The marksman catheter body was found to be kinked at ~25.2cm and ~11.9cm from distal tip.No damages were found with the distal tip.The pipeline flex braid appeared to be stuck inside the marksman catheter hub.The braid was then able to be removed from the hub of the marksman catheter.Upon further analysis of the catheter body it was found under the vis what appeared to be a wire protruding from the catheter body where resistance was felt.The marksman catheter was then cut at the section of resistance and the missing distal segment (tip coil and distal dps restraints) was then removed.The proximal and distal ends of the pipeline flex braid were found fully open.The proximal end of the pipeline flex braid was found to be damaged.The tip coil core wire was found to be broken.The dps sleeves were found to be intact.The ends of the broken pushwire were sent out for sem (scanning electron micrographic) analysis.Based on the investigation conducted resistance can occur during tracking, deployment and re-sheathing of the device in distal and tortuous anatomies.However, the cause for the resistance could not be determined.Based on the investigation conducted, use condition such as excessive force and patient vessel tortuosity can contribute to the event.Separation can occur if excessive force is used exceeding the tensile strength of the material.Two samples of the broken ends of the core wire were sent out for sem (scanning electron micrographic) analysis.Per the sem analysis report for sample 1, the wire exhibits features indicative of tool cutting/snipping.Per the sem analysis report for sample 2, the fracture surfaces exhibit dimple features consistent with torsional overload failure mechanism.However, no definitive conclusions can be provided.From the damages seen on the pipeline delivery system tip coil (stuck within catheter body and broken) and pusher (broken); it appears there was high force used.It is likely these damages occurred when the customer attempted to advance the pipeline flex through the marksman catheter against resistance.However, the cause of the event could not be determined.Related mdrs for this event: 2029214-2019-01245, 2029214-2019-01246.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received report that resistance was experienced when the pipeline flex was advanced with the marksman catheter lumen.A new stent and catheter were used to treat the patient.This event occurred during the treatment of a saccular, left middle cerebral artery aneurysm.The anatomy was minimal in tortuosity.Evaluation of the returned device found that the pipeline flex pushwire was found broken.Also the catheter body it was found under the vis what appeared to be a wire protruding from the catheter body.

• 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: katcha taylor ; 9775 toledo way; irvine, CA 92618 ; 9496801345
• MDR Report Key: 9476944
• MDR Text Key: 208860165
• Report Number: 2029214-2019-01246
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K091559
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/16/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2022
• Device Model Number: FA-55150-1030
• Device Lot Number: 217756445
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/12/2019
• Initial Date FDA Received: 12/16/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/28/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1