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U.S. Department of Health and Human Services

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

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MEDTRONIC IRELAND TURBOHAWK PLUS 6FR CATHETER, PERIPHERAL, ATHERECTOMY Back to Search Results
Model Number THP-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 03/08/2022
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Physician was attempting to use a turbohawk plus directional atherectomy along with non-medtronic 6fr sheath and spider fx guidewire during procedure to treat to treat a severely calcified lesion in the mid superficial femoral artery (sfa) with unknown percentage stenosis. The vessel was little tortuous. The device was inspected with no issues noted. The device was prepped per ifu with no issues identified. It was reported that the wire prolapsed and the tip ended up becoming detached inside the destination sheath 6f. At that time the tip of the turbohawk plus was pulled back into the sheath and got stuck. The tip of the turbohawk plus then became detached while inside the 6f ansel sheath. The physician removed everything at this point (sheath, hawk, sider) in its entirety. Physician then gained access again and completed imaging to ensure no issues. There was no vessel damage. After gaining access again with a new sheath, angioplasty was done to the sfa and procedure was completed as normal with a closure device. There was no patient in jury reported.
 
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Brand NameTURBOHAWK PLUS 6FR
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 Key14014979
MDR Text Key288609733
Report Number9612164-2022-01329
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
Remedial Action Recall
Type of Report Initial
Report Date 04/05/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/05/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberTHP-M
Device Catalogue NumberTHP-M
Device Lot Number0010819446
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/08/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/26/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-0694-2022

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