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

Model Number FA-55150-1030

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Intimal Dissection (1333); Paresis (1998)

Event Date 09/02/2017

Event Type  Injury  

Manufacturer Narrative

The reported device has not been received.The product was not evaluated, therefore the reported event could not be confirmed.The cause of the event could not be conclusively determined from the available information.Should the device be received for evaluation, new information shall be submitted in a follow up report.Marksman instruction for use warns: " never advance or withdraw an intralumenal 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." linked mdr's 2029214-2017-01200 2029214-2017-01201 2029214-2017-01202 2029214-2017-01203.

Event Description

Medtronic received information that a patient had right internal carotid artery dissection and hemiparesis associated with an aneurysm embolization procedure.A flow diversion device was used with a marksman microcatheter for the treatment of the patient's saccular aneurysm located at the right internal carotid artery at ophthalmic segment.The aneurysm measured 6mm in max diameter and 4.10mm in neck diameter and the distal and proximal landing zone artery sizes were 3.4mm and 3.7mm respectively.Vessel tortuosity was described as normal.It was reported the devices were prepared as indicated in the ifu.When the flow diversion device was advanced via the marksman microcatheter, severe resistance was met.It was further reported force was applied during delivery of the flow diverter.The flow diverter was locked up at the distal segment of the marksman microcatheter.The devices were removed from the patient.The marksman microcatheter was noted to have been stretched.

Manufacturer Narrative

Device evaluation: the marksman catheter was returned for evaluation.Based on analysis, no evidence was found to suggest that the marksman failed to meet specifications.All products are 100% inspected for damage and irregularities during manufacture.The event occurred in the patient post-procedure and its cause could not be conclusively determined from the reported information.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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
• Manufacturer (Section G): COVIDIEN, IRVINE; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 9496801224
• MDR Report Key: 6992305
• MDR Text Key: 90736169
• Report Number: 2029214-2017-01203
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K091559
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 03/09/2018
• Device Model Number: FA-55150-1030
• Device Lot Number: A070874
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2015
• 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: 65 YR