MAUDE Adverse Event Report: MEDTRONIC MARKSMAN; CATHETER, CONTINUOUS FLUSH

Model Number FA-55150-1030

Device Problems Deformation Due to Compressive Stress (2889); Physical Resistance/Sticking (4012)

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

Event Date 06/02/2021

Event Type  malfunction  

Manufacturer Narrative

As found condition: the pipeline flex device and marksman micro catheter were returned for analysis within a shipping box; within an unsealed plastic biohazard pouch; within an opened pipeline flex inner pouch and within a dispenser coil.The two opened outer cartons were also returned.Visual inspection/damage location details: no flash or voids molded were found within the marksman micro catheter hub.Liquid blood was found within the hub.No damages or anomalies were found with the marksman micro catheter hub.The marksman catheter was found broken at ~10.6cm from the proximal end with the inner wire also broken.The distal ~29.6cm of the marksman catheter was found kinked and flattened.The marksman catheter tip and marker band were also found flattened.The pipeline flex pusher was found extending out the marksman catheter hub.The pipeline flex was retracted out of the catheter against high resistance.The hypotube was found intact and unstretched with the ptfe shrink tubing intact.The distal wire was separated from the hypotube proximal to the wire weld and remained stuck within the marksman catheter.The catheter was cut to extract the distal wire and braid.The re-sheathing marker and proximal bumper were found separated from the distal wire and found within the braid.No damages were found with the distal marker.The distal and proximal dps restraints were found to be intact.The dps sleeves were found intact with no signs of damage.The tip coil was found damaged.The proximal braid was found tapered, damaged.And frayed.The distal braid was found fully opened, damaged and frayed.Testing/analysis: the marksman micro catheter total length was measured to be ~158.3cm and the usable length was measured to be ~153.0cm, which is within specification (specification: total (ref) = 157cm ± 3cm; usable = 150cm ± 3cm).The inner diameter was measured to be 0.027¿ at the proximal which is within specification and compatible for use with the pipeline flex (specification: 0.027¿ ±0.001¿).The distal tip inner diameter could not be measured as it was destroyed during the extraction of the distal wire and braid.Conclusion: based on the analysis findings, the customer report of ¿lockup/resistance at distal segment of catheter¿ was confirmed.Possible causes are damaged catheter, damage to ped or pushwire, frayed ends on braid, patient vessel tortuosity, user does not maintain continuous flush, user pulls back on/torques wire advancing ped in micro catheter.From the damages seen on the braid (damaged/frayed); distal wire (separation), proximal bumper/resheathing pad (separation) tip coil (damage), and catheter (kink/flatten/break); it appears there was high force used.It is possible these damages occurred when the customer attempted to advance/retrieve the pipeline flex w/ shield through the marksman catheter against the reported resistance.Possible contributors towards the failure are patient vessel tortuosity, or lack of continuous flush.There was no non-conformance to specifications identified that led to the reported issues.The distal wire of the pipeline flex w/ shield delivery system was possibly detached due to the solder tensile failure when attempting to retract the pipeline flex w/ shield against the reported resistance.A review of the manufacturing process (mp1664, mp1647, mp1720, <(><<)>(><(>&<)><(><<)>)> vs2022) did not uncover any deficiencies with regards to the soldering process.Proper soldering technique and surface preparation (tinning) were well defined and documented appropriately in the associated manufacturing procedures.In addition, the elemental analysis conducted through scanning electron micrographic (sem) / energy dispersive spectroscopy (eds) showed presence of soldering material (tin); thereby indicating that the soldering was conducted.The proof load of 2.5n performed on 100% of the devices (section starting with hypotube solder to distal pad solder joint).There was no non-conformance to specification that led to the detachment issues.There is no indication that the event is related to a potential manufacturing issue.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a pipeline device and marksman microcatheter that hard resistance together and the marksman had accordion damage.The patient was undergoing a procedure for flow diverter treatment of an unruptured saccular wide-necked aneurysm in the clinoid procedure of an internal carotid artery.The aneurysm max diameter was 9.3mm and the neck diameter was 8.7mm.Vessel tortuosity was minimal.It was reported that all devices were prepared according to the instructions for use (ifu).Intraoperative puncture and access were established.After the marksman was in place, the pipeline was introduced.The catheter was flushed continuously with heparinized s aline per ifu and it was noted the hydration was good.However, the physician observed that there was significant resistance during the delivery of the pipeline and it could not be pushed out the distal end of the marksman microcatheter.After repeated adjustments, the pipeline still could not be delivered and deployed.The whole system was withdrawn and accordion damage was observed at the distal tip of the marksman microcatheter.There was no damage observed to the pipeline pushwire.Both devices were replaced to complete the procedure.There was no harm or injury to the patient.

• Brand Name: MARKSMAN
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): MEDTRONIC; irvine,ca
• Manufacturer (Section G): MEDTRONIC; irvine,ca
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 12662236
• MDR Text Key: 277422644
• Report Number: 2029214-2021-01311
• 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: 10/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/23/2023
• Device Model Number: FA-55150-1030
• Device Catalogue Number: FA-55150-1030
• Device Lot Number: 221199920
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2021
• Date Manufacturer Received: 10/18/2021
• Date Device Manufactured: 11/23/2020
• 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: 66 YR