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

Model Number FA-55150-1030

Device Problems Collapse (1099); Physical Resistance/Sticking (4012)

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

Event Date 08/26/2020

Event Type  malfunction  

Manufacturer Narrative

The pipeline flex was stuck inside the broken/separated marksman catheter.The pipeline flex could not be pushed forward or removed.For further examination, the catheter was cut to remove the pipeline flex delivery system.When compared to the drawings the distal and proximal dps restraints were found to be intact.The dps sleeves were found intact with no signs of damage.The distal hypotube and ptfe shrink tubing were found to be intact with no signs of elongation.The distal and proximal ends of the pipeline flex braid were found fully opened and moderate frayed.No bend found on the pipeline flex pusher.No damages were found with the distal marker, re-sheathing marker, re-sheathing pad or with the proximal bumper.The total and usable lengths of the catheter were measured to be within specifications.The marksman catheter appeared to be separated in two segments.The catheter was separated at 32.5cm from distal tip.The catheter tip and the marker band were examined; and no damages were found d.In addition, the catheter body was found to be accordioned from 31.5cm to 23.0cm from distal tip.No flash or voids molded were observed in the hub.The catheter was flushed, and water exited out from the distal tip.The catheter was then tested by running an in-house 0.0265¿ mandrel through catheter tip and hub.The mandrel could pass through the catheter tip and hub with no issues; however, resistance was observed at the damaged locations.No other anomalies were observed.Based on the analysis findings, the pipeline flex and marksman were confirmed to have resistance during delivery and catheter damage/separation as the returned pipeline flex was stuck inside the marksman catheter and catheter was separated.In addition, the pipeline flex and the marksman catheter were found to be damaged.From the damages seen on the catheter body (accordioning/separating), and pipeline flex braid (fraying); it appears there was high force used.It is likely these damages occurred when the customer attempted to advance and retrieve the pipeline flex through the marksman catheter against resistance.It is likely that patient tortuous anatomy may have contributed to the reported issues.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a report that the pipeline became stuck in the marksman catheter.It was reported that after the marksman catheter was placed in the distal middle cerebral artery, the pipeline could not pass through the catheter normally during delivery.The pipeline became stuck in the distal portion of the catheter, and the devices could only be withdrawn as a whole.The physician had tried to release the load/slack in the system, but this did not resolve the issue.It was observed that the distal portion of the marksman was flattened and deformed.There was no damage to the pushwire.The patient did not experience any injury or complications.Dual antiplatelet treatment was administered for seven days, and the patient¿s pru level was normal.The devices were prepared according to the instructions for use (ifu).The patient was undergoing treatment for an unruptured, saccular aneurysm located on the left side.The max diameter was 6.0 mm.The neck was 4.5 mm.The artery landing zone was 2.87 mm distal and 3.03 mm proximal.The patient¿s vessel tortuosity was moderate.Ancillary devices include a cook 6f sheath, navien 5f guide catheter, and a synchro-14 guidewire.

• 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: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 7635140379
• MDR Report Key: 10908679
• MDR Text Key: 219526087
• Report Number: 2029214-2020-01189
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00847536026261
• UDI-Public: 00847536026261
• 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: Other
• Type of Report: Initial
• Report Date: 11/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/30/2022
• Device Model Number: FA-55150-1030
• Device Catalogue Number: FA-55150-1030
• Device Lot Number: 218155356
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2020
• Date Manufacturer Received: 11/16/2020
• Date Device Manufactured: 07/30/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 28 YR