MAUDE Adverse Event Report: COVIDIEN (IRVINE) MARKSMAN; CATHETER, CONTINUOUS FLUSH

Model Number FA-55160-1030

Device Problems Break (1069); Difficult or Delayed Activation (2577)

Patient Problem Ischemia (1942)

Event Date 01/06/2019

Event Type  Injury  

Manufacturer Narrative

The marksman catheter was not returned for analysis; therefore, no definitive conclusion can be drawn regarding the clinical observation.However, the device is pending return.Upon receipt of the device a supplemental report will be filed.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during a thrombectomy case, about 1cm of the marksman catheter tip separated during the procedure.It was reported that the separated catheter tip was migrated from internal carotid artery (ica) to anterior cerebral artery (aca).The aca was reported occluded with the tip.The tip was unable to retrieved and this cause a new ischemic event in the aca.The patient is pelagic on the left side and is currently in rehab.The patient is ¿doing as well as the physician could expect her to be doing¿.Per physician there was a kink in the sheath which he thinks ¿ultimately may have been the problem¿ causing the catheter to fracture 1cm proximal to the marker band.

Manufacturer Narrative

H3: the marksman catheter (model: fa-55160-1030 lot: 216326976) was returned for analysis within a shipping box; within a plastic bio-pouch and within an opened marksman inner pouch.The (stryker) infinity sheath and (penumbra) ace 68 catheter were not returned.The ace 68 catheter has a proximal and distal od (outer diameter) of 6fr (0.080¿) and the infinity sheath has an id (inner diameter) of 0.088¿, as per online sources.Per the marksman ifu (instructions for use), marksman is compatible for use with guide catheters with a minimum od of 5fr.Therefore, the ace 68 catheter was found to be compatible for use with marksman.In addition, it appears the ace 68 catheter is compatible for use with the infinity sheath.The marksman total length was measured to be ~168.2cm (reference: 167cm ± 3) and the useable length was measured to be ~160.7cm which is within specification (specification: 160cm ± 3).Upon visual inspection, no issues or irregularities were observed with the marksman hub.The marksman catheter body was found to be flattened at ~21.4cm to ~10.5cm from the distal end.In addition, the marksman catheter body was found kinked at ~8.5cm from the distal end.Approximately 2mm of the marksman distal marker band/tip was found dislodged from the catheter.It was reported the dislodged marker band/tip remains within the patient.The outer tubing material of the separated end exhibited with plastic deformation (jagged edges and stretching) with the inner wire stretched and protruding from between the inner liner and outer tubing.There does not appear to be any separation of the inner liner.The marksman catheter was flushed, water and blood exited from the distal end.No other anomalies were observed.The marksman catheter was returned for analysis without the (stryker) infinity sheath and (penumbra) ace 68 catheter.Therefore, any contributing factors (other than inner/outer diameter specifications) could not be assessed.The marksman catheter body was found to be flattened at ~21.4cm to ~10.5cm from the distal end.In addition, the marksman catheter body was found kinked at ~8.5cm from the distal end.Approximately 2mm of the marksman distal marker band/tip was found dislodged from the catheter.It was reported the dislodged marker band/tip remains within the patient.The outer tubing material of the separated end exhibited with plastic deformation (jagged edges and stretching) with the inner wire stretched and protruding from between the inner liner and outer tubing.There does not appear to be any separation of the inner liner.Based on the device analysis and reported information, the customer¿s report of ¿difficult navigation¿ could not be confirmed.However, regarding the customer¿s report of ¿catheter separation/break¿, the issue was confirmed.Based on the reported information, it is likely the ¿kink¿ observed with the infinity sheath may have contributed to the events subsequently damaging the marksman.In addition, highly tortuous anatomy and/or other contributing factors such as kink/damage to guidewire/stents can contribute to resistance during delivery, subsequently causing the marksman catheter to become damaged.Information regarding patient vessel tortuosity and possible kink/damage to guidewire/stents was not provided.Therefore, any contributing factors could not be assessed.If there are hard clots /calcifications in the navigation tract which may snag the catheter, they may have been detected under fluoroscopic use of the product and as instructed in ifu, without observing the resultant tip r esponse, the catheter shouldn¿t be attempted to move further.For the marker band to dislodge from the catheter the distal shaft needs to be damaged and/or separated from the catheter, which is unlikely to occur without experiencing excessive resistance.In additi on, device incompatibility and lack of continuous flush can contribute to the event.The ace 68 catheter was found to be compatible for use with marksman.In addition, it appears the ace 68 catheter is compatible for use with the infinity sheath.However, information regarding use of continuous flush was not provided.Therefore, any contributing factors could not be assessed.Image review of angiograms taken intra-operatively confirm the presence of an embolus in the right anterior cerebral artery leading to occlusion of that vessel at the junction of a1/a2 aca segment.Flow in the right middle cerebral artery appears to be satisfactory tici ii.The embolus noted in the aca suggests it is part of the distal tip of the mrksman microcatheter.One could not conclusively determine why the tip separation had occurred.Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the fda 3500a form and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.Medtronic objects to the use of these words and others like it because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.

• Brand Name: MARKSMAN
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• MDR Report Key: 8302534
• MDR Text Key: 134919101
• Report Number: 2029214-2019-00073
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00847536026278
• UDI-Public: 00847536026278
• Combination Product (y/n): N
• PMA/PMN Number: K091559
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/09/2021
• Device Model Number: FA-55160-1030
• Device Catalogue Number: FA-55160-1030
• Device Lot Number: 216326976
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2019
• Initial Date Manufacturer Received: 01/09/2019
• Initial Date FDA Received: 02/04/2019
• Supplement Dates Manufacturer Received: 03/04/2019
• Supplement Dates FDA Received: 03/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability