• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROVENTION, INC. HEADWAY 17 MICROCATHETER

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MICROVENTION, INC. HEADWAY 17 MICROCATHETER Back to Search Results
Model Number MC172150SX
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Hemorrhage, Cerebral (1889)
Event Date 05/25/2017
Event Type  Death  
Manufacturer Narrative

The lot number information was not provided; therefore, the device history record (dhr) could not be reviewed. The device was discarded at the user facility; therefore, a product analysis could not be performed. There was no reported device malfunction. The physician stated that the hemorrhage from the vessel dissection was straightening of the vessel when the microcatheter crossed the target area. The instructions for use (ifu) identifies hemorrhage and death as potential complications associated with use of the device. The device was used during the same procedure as was reported in mfr. Report# 2032493-2017-00151.

 
Event Description

It was reported that a stent-assisted coiling treatment was performed on an anterior communication artery (a-comm) aneurysm via the right internal carotid artery, on a patient with 4-5 aneurysms in the intracranial vasculature. The microcatheter was placed across the a1 to the contralateral a2, and the stent was advanced through the microcatheter then deployed. The stent looked well apposed. The microcatheter was re-crossed through the deployed stent to attempt an exchange for a smaller microcatheter in order to access one of the cells. A few minutes later, a severe bleed was discovered with roadmap imaging; however, the source of the bleed could not be determined. Protamine was administered to the patient and a temporary coil was placed in the right a1 to stop the bleeding. Once the bleeding stopped, the previous angiograms were reviewed. The images revealed the bleeding was present prior to the stent implantation and the tortuous a2 to the a-comm to the contralateral a2 vessel segment was straightened out by the microcatheter. Surgical intervention was performed to relieve intracranial pressure and evacuate clot. It was the consensus of two physicians that there was a spontaneous/spiral dissection that resulted from the straightening out of the vessel during access by the microcatheter and the stent tracking through it. Four (4) days after the procedure, the patient died. The physician stated the cause of death was hemorrhage from the vessel dissection caused by straightening of the vessel when the microcatheter crossed the target area. There was no reported device malfunction.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameHEADWAY 17 MICROCATHETER
Type of DeviceMICROCATHETER
Manufacturer (Section D)
MICROVENTION, INC.
1311 valencia avenue
tustin CA 92780
Manufacturer Contact
debby callahan
1311 valencia avenue
tustin, CA 92780
MDR Report Key6665744
MDR Text Key78343906
Report Number2032493-2017-00152
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK083343
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 05/25/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/23/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator OTHER
Device MODEL NumberMC172150SX
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/25/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 06/23/2017 Patient Sequence Number: 1
-
-