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U.S. Department of Health and Human Services

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

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MEDTRONIC IRELAND HAWKONE 6F CATHETER, PERIPHERAL, ATHERECTOMY Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Occlusion (1984); Stenosis (2263); Vascular Dissection (3160); No Code Available (3191)
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 2019 and has performed a total of 200 procedures using this system. During use of the hawkone 6f directional atherectomy system the respondent reports encountering the following device related complications: arterial dissection, arterial spasm, entry site complications, restenosis of the treated segment, total occlusion of the peripheral artery events were deemed device related. The total occlusion of the peripheral artery event was reported to be very concerning. The respondent classified the arterial dissection and restenosis of the treated segment events as somewhat concerning. The arterial spasm and entry site complications events were regarded as being not at all concerning.
 
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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 Key9346809
MDR Text Key167136053
Report Number9612164-2019-04818
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
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