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

MAUDE Adverse Event Report: MEDTRONIC IRELAND HAWKONE TURBOHAWK CATHETER, PERIPHERAL ATHERECTOMY

  • 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
 

MEDTRONIC IRELAND HAWKONE TURBOHAWK CATHETER, PERIPHERAL ATHERECTOMY Back to Search Results
Model Number HI - S
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 10/29/2018
Event Type  Injury  
Event Description
Tip of hawk one became disconnected, and was inside the artery.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameHAWKONE TURBOHAWK
Type of DeviceCATHETER, PERIPHERAL ATHERECTOMY
Manufacturer (Section D)
MEDTRONIC IRELAND
MDR Report Key8074326
MDR Text Key127356545
Report NumberMW5081284
Device Sequence Number0
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 11/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/14/2018
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/25/2021
Device Model NumberHI - S
Device Lot Number0009256641
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 11/14/2018 Patient Sequence Number: 1
-
-