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

Model Number FA-55150-1030

Device Problems Stretched (1601); Physical Resistance/Sticking (4012)

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

Event Date 07/16/2020

Event Type  malfunction  

Manufacturer Narrative

The pipeline flex device was returned stuck inside the distal segment of the marksman catheter.The pipeline flex could not be pushed forward or removed.For further examination, the catheter was cut to remove the pipeline flex from the catheter lumen.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 appeared to be stretched with the ptfe shrink tubing still intact.When pushing the pipeline flex braid out from the catheter lumen, the distal and proximal ends of the pipeline flex were found fully opened and moderately frayed.No bends or kinks were found with 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 catheter tip and marker were examined; and no damages were found.The catheter body was found to be separated at ~32.0cm from distal end.In addition, the catheter body found to be accordioned from ~29.5cm to ~31.3cm from the distal tip.No flash or voids molded were observed in the hub.The catheter was then tested by running an in-house 0.0265¿ mandrel through catheter tip and hub.The mandrel successfully passed through the catheter hub and tip with no issues; however, the resistance observed at the damaged locations.Based on the analysis findings, the pipeline flex and marksman were confirmed to have resistance during delivery as the returned pipeline flex was stuck inside the marksman catheter.The pipeline flex and the marksman catheter were found to be damaged.From the damages seen on catheter body (accordioning/separating), pipeline flex braid (fraying) and hypotube (stretching); 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.It is likely that patient tortuous anatomy may have contributed to the resistance during delivery.The customer reported that the devices were prepared per the ifu and c continuous flush was maintained during delivery.Based on the returned devices, there was no non-conformance to specifications identified that led to the resistance during delivery issue.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a pipeline which had resistance and became stuck in a marksman microcatheter.The patient was being treated for a ruptured saccular aneurysm of the right ophthalmic artery.The aneurysm max diameter was 6mm and the neck diameter was 5mm.Vessel tortuosity was severe.It was reported that first a phenom27 microcatheter was going to be used but during preparation the catheter was observed to be kinked so it was replaced with a marksman catheter.The devices were prepared and used per instructions for use (ifu).The catheter was flushed per ifu.The intracranial support catheter was to the aneurysm site.The marksman was then advanced into the m1 segment.The pipeline was advancing through the marksman but began having resistance in the middle section and could not track to the deployment location and the pipeline became stuck in the distal end.Multiple attempts were made to adjust placement of the support catheter and microcatheter as well as release the slack in the system but the pipeline still could not be moved.The surgeon then removed the pipeline and marksman together and it appeared they may have been stretched and the pipeline pushwire kinked.The catheter was flushed continuously during the procedure with heparinized saline.The procedure was ultimately completed with successful coil compaction of the aneurysm though it was determined a pipeline should still be placed at a later date.There was no harm or injury to the patient.Ancillary devices: navien intracranial support catheter, non-medtronic sheath and guidewire there was very little resistance, if any, when attempting to remove the marksman and pipeline.The resistance was within the marksman.

• 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: 10659776
• MDR Text Key: 212783059
• Report Number: 2029214-2020-01010
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00836462014077
• UDI-Public: 00836462014077
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091559
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/21/2022
• Device Model Number: FA-55150-1030
• Device Catalogue Number: FA-55150-1030
• Device Lot Number: 218286978
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/26/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/21/2019
• 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
• Patient Age: 35 YR