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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC IRELAND TURBOHAWK PLUS 7FR CATHETER, PERIPHERAL, ATHERECTOMY

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MEDTRONIC IRELAND TURBOHAWK PLUS 7FR CATHETER, PERIPHERAL, ATHERECTOMY Back to Search Results
Model Number THP-LX
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Perforation (2001); Vascular Dissection (3160)
Event Date 02/07/2022
Event Type  Injury  
Event Description
Physician was attempting to use the turbohawk plus atherectomy device during procedure to treat lesion in the mid superficial femoral artery (sfa). The vessel had no tortuosity. The device was inspected with no issues noted. The device was prepped per the ifu was no issues identified. It was reported that vessel damage/injury occurred. It was reported that dissection/perforation occurred. No issue with turbohawk device during use. Unknown if device contributed to the vessel dissection/perforation/injury. No resistance encountered during advancement/withdrawal of the device. Device was safely removed from patient. A covered stent was used to fix the issue. No further patient injury reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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Brand NameTURBOHAWK PLUS 7FR
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
alison sweeney
parkmore business park west
galway 
EI  
091708096
MDR Report Key13618746
MDR Text Key286236815
Report Number9612164-2022-00817
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K212027
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/10/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/28/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberTHP-LX
Device Catalogue NumberTHP-LX
Device Lot Number0010772877
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/09/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/21/2021
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: 02/28/2022 Patient Sequence Number: 1
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