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

Model Number FA-55150-1030

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

Patient Problems Intracranial Hemorrhage (1891); Hemorrhage, Subarachnoid (1893); Perforation of Vessels (2135)

Event Date 04/03/2020

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a report that vessel perforation occurred during deliver of the marksman microcatheter leading to hemorrhaging.The patient was undergoing surgery for treatment of a thrombectomy of the right cervical internal carotid artery and m1 proximal site of the right middle cerebral artery (mca).It was noted the patient's vessel tortuosity was unknown.It was reported that after the thrombectomy with trevo for the third time, there was distal embolism to the right m2 site.An attempt was made to deliver the marksman microcatheter and guidewire, but vascular perforation occurred.Coil embolization was then performed to treat the vessel perforation.A stent retriever and aspiration catheter was used to treat the distal embolism.On (b)(6) 2020, symptomatic intercranial hemorrhage and subarachnoid hemorrhage were confirmed on ct and mri.The doctor believed the hemorrhaging was due to the perforation of the blood vessel.It was unknown if the devices were prepared and hydrated per the instructions for use (ifu).It was unknown if there was an resistance encountered, or if any surgical or medical procedures had been performed.

• 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: 10471607
• MDR Text Key: 204943392
• Report Number: 2029214-2020-00866
• 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,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/31/2020

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 Model Number: FA-55150-1030
• Device Catalogue Number: FA-55150-1030
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/24/2020
• Initial Date FDA Received: 08/31/2020
• 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 Outcome(s): Required Intervention
• Patient Age: 66 YR