• 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 6F 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 6F CATHETER, PERIPHERAL, ATHERECTOMY Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Embolism (1829); Thrombosis (2100); Vascular Dissection (3160)
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic conducted a post market clinical follow-up (pmcf) survey to seek out potential new risks and assess performance medtronic¿s hawkone 6f directional atherectomy system. Survey results are received for a interventional cardiologist practicing in (b)(6). The respondent has been using the hawkone 6f directional atherectomy system since 2018 and has performed 150 atherectomy procedures overall and 100 within the last 12 months using this system. During use of the hawkone 6f directional atherectomy system the respondent reports encountering the following complications: arterial dissection, arterial spasm, and embolism or arterial thrombosis. The arterial dissection was regarded as being somewhat concerning and was treated with stent implantation. The complication was deemed device related. The arterial spasm event was considered to be not at all concerning, and was treated with vasodilators, but was attributed to use of the device. The embolism or arterial thrombosis event which was considered very concerning was reported to have been a distal embolization (anterior tibial artery) after directional atherectomy at the tripod and was resolved with balloon dilatation. This was also deemed to be a device related event.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameHAWKONE 6F
Type of DeviceCATHETER, PERIPHERAL, ATHERECTOMY
Manufacturer (Section D)
MEDTRONIC IRELAND
parkmore business park west
galway
Manufacturer (Section G)
MEDTRONIC IRELAND
parkmore business park west
galway
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
091708734
MDR Report Key9346885
MDR Text Key167136769
Report Number9612164-2019-04821
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K161361
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 11/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/20/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/15/2019
Was Device Evaluated by Manufacturer? No Answer Provided
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: 11/20/2019 Patient Sequence Number: 1
-
-