• 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 6FR 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 6FR CATHETER, PERIPHERAL, ATHERECTOMY Back to Search Results
Model Number H1-M
Device Problems Detachment of Device or Device Component (2907); Difficult to Advance (2920)
Patient Problem Unspecified Tissue Injury (4559)
Event Date 10/19/2021
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Physician was attempting to use the hawkone atherectomy device during procedure to treat severely calcified plaque in the mid proximal left common iliac artery and superficial femoral artery (sfa). Vessel had moderate tortuosity and cto (chronic total occlusion-100%). A non medtronic 6fr sheath and non-medtronic 0. 014'' guidewire were used. The vessel was pre and post dilated. Ifu was followed. It was reported that there was tip detachment/tip damage. Moderate resistance was felt during withdrawal. The tip detached at the hinge pin. The wire was prolapsed physician felt minor resistance when bringing the hawkone back into the sheath. It detached at the hinge pin and tip was left in the sfa until it could be snared and taken out. The procedure was completed by snaring the nose cone of the hawkone and proceeding with procedure with no effect. Dcb and stents were deployed. No patient injury reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameHAWKONE 6FR
Type of DeviceCATHETER, PERIPHERAL, ATHERECTOMY
Manufacturer (Section D)
MEDTRONIC IRELAND
parkmore business park west
galway
EI
Manufacturer (Section G)
MEDTRONIC IRELAND
parkmore business park west
galway
EI
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
EI  
091708734
MDR Report Key12680512
MDR Text Key277859641
Report Number9612164-2021-04059
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K161361
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup,Followup
Report Date 02/18/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberH1-M
Device Catalogue NumberH1-M
Device Lot Number0010730248
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/19/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/21/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-0450-2022

Patient Treatment Data
Date Received: 10/22/2021 Patient Sequence Number: 1
-
-