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U.S. Department of Health and Human Services

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

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MEDTRONIC IRELAND TURBOHAWK CATHETER, PERIPHERAL, ATHERECTOMY Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Embolism (1829); Perforation (2001); Thrombosis (2100)
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 the performance of turbohawk and silverhawk peripheral plaque excision systems. Survey results received for an interventional cardiologist with 12 years¿ experience who was been using the turbohawk peripheral plaque excision system since 2012. The physician has used a total of 60 turbohawk peripheral plaque excision systems with 12 of these being used in the past 12 months. The physician reported the device related complications of arterial perforation which leads to immediate pain in the patient and has so far been well sealed with prolonged pta, and embolism or arterial thrombosis which can occur when the filter wire slides or this does not seal well against the vessel wall, for example in case of wall irregularity. Often also mobilized plaques hang on the edge of the filter. During recovery of the filter, this can embolise. Often, plaque material is found after filter removal in the lock, so it must be well aspirated after recovery and then rinsed. The embolism that has taken place so far has been successfully aspirated. None of these events were reported previously to medtronic. The physician all of the events to be not at all concerning. The physician has not used the silverhawk peripheral plaque excision system.
 
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Brand NameTURBOHAWK
Type of DeviceCATHETER, PERIPHERAL, ATHERECTOMY
Manufacturer (Section D)
MEDTRONIC IRELAND
parkmore business park west
galway MN
Manufacturer (Section G)
MEDTRONIC IRELAND
parkmore business park west
galway MN
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
091708734
MDR Report Key9450845
MDR Text Key171578863
Report Number2183870-2019-00577
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
K170191
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/11/2019
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 Received02/19/2020
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: 12/11/2019 Patient Sequence Number: 1
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