MAUDE Adverse Event Report: 9775 TOLEDO WAY MARKSMAN; CATHETER, CONTINUOUS FLUSH

Model Number FA-55150-1030

Device Problem Break (1069)

Patient Problems Neurological Deficit/Dysfunction (1982); Foreign Body In Patient (2687)

Event Date 01/02/2018

Event Type  Injury  

Manufacturer Narrative

The device was not returned for analysis.Attempts have been made to obtain additional information, however, our attempts have been unsuccessful.As the device was not returned, we are unable to perform further root cause analysis.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during a mechanical thrombectomy stroke case, the distal part of the microcatheter was reported to have fractured and remains in the patient.The patient condition is unknown at this time.

Manufacturer Narrative

Received additional information stating the patient's vasculature was moderately tortuous and the access vessel was the femoral artery.There was no force applied during delivery or removal of the microcatheter.There was no damage to the stent and the microcatheter was not shaped.There was also no signs of vasospasm.The broken distal tip of the patient was reported to be in the m2 segment of the mca.The patient was reported to be intact and has recovered from the stroke and has small visual field defect from the stroke.The device has been returned and the evaluation is in progress.A supplemental report will be submitted once the analysis is complete.(b)(4).If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

The marksman micro catheter was returned for analysis; without the sofia guide catheter or solitaire 2 revascularization device; therefore, any contributing factors from these devices could not be assessed.And visual inspection showed no issues or irregularities.The marksman micro catheter body was found to be kinked at near the distal tip and flattened at approximately 29.3cm from the distal end until the distal end of the catheter.Approximately 8.5cm of the distal inner wire was found to be missing from within the catheter.The marksman micro catheter distal marker band and approximately 1mm of the distal tip was found to be missing from the catheter.It was reported the distal marker band and tip remains within the patient.The outer tubing material and inner liner at the separated distal end exhibited jagged edges and stretching.No other anomalies were observed.Based on the device analysis and reported information, the customer¿s report of ¿catheter separation/break¿ was confirmed.The returned marksman micro catheter was found to be kinked and flattened.In addition, the marksman micro catheter distal marker band and tip were found to be separated and missing from the micro catheter.The outer tubing material of the separated end exhibited plastic deformation (jagged edges and stretching ) which indicated the catheter separated when exceeding the tensile strength of the tubing material.A formal investigation was conducted.Possible causes for the reported event could be attributed to highly tortuous anatomy, kinked or damage ancillary devices (i.E.Guide catheter, balloon guide catheter, guidewire, stents) which may cause resistance during delivery and/or retrieval.The patient¿s anatomy was reported to be ¿moderate¿.In addition, there was no vessel calcification or stenosis noticed or vasospasm.The kinking and flattening of the returned marksman micro catheter is consistent with damage caused by resistance.However, it was reported there was no kink or damage to the sofia guide catheter and no resistance during delivery and/or retrieval within the guide catheter.It was further reported there was no damage to the solitaire 2 revascularization device.Therefore, the cause for the reported event could not be determined.The lot history record review of the reported lot number showed no discrepancies that would have contributed to the reported experience.In addition, all products are 100% inspected for damages and irregularities during manufacture.Therefore, manufacturing has been ruled out as a potential cause.As noted in the marksman ifu (instructions for use): ¿the catheter should be manipulated under fluoroscopy only.Do not attempt to move the catheter without observing the resultant tip response.Never advance or withdraw an intraluminal device against resistance until the cause of resistance is determined by fluoroscopy.If the cause cannot be determined, withdraw the catheter.Movement of the micro catheter against resistance may result in damage to the micro catheter, or the vessel.¿ if information is provided in the future, a supplemental report will be issued.

• Brand Name: MARKSMAN
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): 9775 TOLEDO WAY; irvine CA 92618
• Manufacturer (Section G): 9775 TOLEDO WAY; irvine CA 92618
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 9492753836
• MDR Report Key: 7226550
• MDR Text Key: 98516954
• Report Number: 2029214-2018-00067
• Device Sequence Number: 1
• Product Code: KRA
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/02/2020
• Device Model Number: FA-55150-1030
• Device Lot Number: 213532652
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/03/2017
• 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 Outcome(s): Disability
• Patient Age: 68 YR
• Patient Weight: 57