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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC IRELAND HAWKONE 6FR CATHETER, PERIPHERAL, ATHERECTOMY

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MEDTRONIC IRELAND HAWKONE 6FR CATHETER, PERIPHERAL, ATHERECTOMY Back to Search Results
Catalog Number H1-M
Device Problem Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/30/2018
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
The physician attempted to use a hawkone directional atherectomy catheter and a 6mm spider filter guidewire to treat a 300mm fibrous cto (chronic total occlusion-100%) with little calcification in the right superficial femoral artery. The artery had a 6mm diameter and had little tortuosity. The procedure used a 6 fr non-mdt sheath. The vessel was pre and post dilated. The devices were prepped as per the ifu and the guidewire was hydrated during prep. It was reported that severe resistance was encountered advancing the device. The device was advanced over bifurcation. The guidewire locked up on the hawkone and the wire separated through the side of the device tip. Tip damage was reported on the hawkone. The device was removed by pulling the guidewire from the lumen with resistance. It was further reported the device was loaded correctly while advancing the wire separated from the device. No detachment occurred. The tecothane jacket is reported to have torn. The procedure was completed using a drug coated balloon. No patient complications have been reported as a result of this event.
 
Manufacturer Narrative
The hawkone was returned connected to a cutter driver. No ancillary devices were included. The hawkone was visually inspected and it was noted that the guidewire tubing was damaged. The guidewire lumen of the rotating tip showed that the proximal end was buckled and pointed upwards from the tip. A yellow/green debris was observed between the rotating tip lumen and the housing lumen. The debris was likely ptfe from the capture wire of the spider fx. The guidewire tubing of the housing segment showed a zipper tear throughout the segment. It was discovered the yellow/green debris was observed on the outside of the torque shaft adapter. The drive shaft was bent at an approximate 90 degree bend at the strain relief. No other damages to the hawkone was observed. Functional testing was performed and a 0. 014" guidewire from the lab was front-loaded. The guidewire entered the tip, but was protruding out from the beginning of the tear. The guidewire was back-loaded and the tear was evident throughout the segment. The guidewire could not be loaded. If information is provided in the future, a supplemental report will be issued.
 
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Brand NameHAWKONE 6FR
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 Key8124903
MDR Text Key129054714
Report Number9612164-2018-03450
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 company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/21/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/03/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/23/2021
Device Catalogue NumberH1-M
Device Lot Number0009295323
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/06/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/04/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/24/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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