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U.S. Department of Health and Human Services

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

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MEDTRONIC IRELAND ATK TURBOHAWK SMOOTH CATHETER, PERIPHERAL, ATHERECTOMY Back to Search Results
Model Number TH-LX-M
Device Problems Detachment of Device or Device Component (2907); Difficult to Advance (2920)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/07/2022
Event Type  malfunction  
Event Description
Physician was attempting to use turbohawk directional atherectomy along with non-medtronic 7fr sheath, guidewire and 7mm embolic protection during procedure to treat a moderately calcified lesion in the right proximal superficial femoral artery (sfa) with chronic total occlusion (cto-100%). The vessel was none tortuous. The vessel diameter and lesion length are 6mm and 100mm respectively. Thevessel was not pre dilated but post dilated. Ifu was followed. It was reported that moderate resistance occurred during withdrawal and the tip detached but did not separate at the hinge pin. The nosecone detached from cutter. The device would not come out of sheath and when finally removed, the nose cone was separated from cutter. The device was safely removed from patient. The was no patient injury reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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Brand NameATK TURBOHAWK SMOOTH
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 Key13730769
MDR Text Key287184757
Report Number9612164-2022-00954
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K111723
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 06/24/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/11/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberTH-LX-M
Device Catalogue NumberTH-LX-M
Device Lot Number0010667121
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/23/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/04/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No

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