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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); Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/01/2022
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 during procedure along with non-medtronic 6fr sheath and 0. 014" guidewire during procedure to treat a moderately calcified soft tissue lesion in the right mid superficial femoral artery (sfa) and popliteal artery (pop) with 60% stenosis. The vessel was moderately tortuous. The vessel diameter and lesion length are 5mm and 40mm respectively. The vessel was not pre dilated but post dilated. Ifu was followed. Tip detachment/damage occurred with a moderate resistance felt during advancement. The tip did not separate at the hinge pin. It was reported that after the first pass/cut was made with the turbohawk, when tech pulled thumb switch back to turn off device, it did not want to completely shut off. Therefore, the tech proceeded to turn off the battery pack and the device was removed. The physician did not want to waste time and asked for the device to be put in a biohazard bag. A hawkone was then attempted to continue procedure, and it was reported that when advancing the hawkone-s, physician felt a lot of resistance, after getting it through the sheath, the device performed well. When removing the device, physician felt event more resistance than when advancing it. The catheter came out without the nosecone. The nosecone stayed stuck in the proximal end of the sheath. Physician continued to remove wire, while thinking of removing the entire sheath, but then the detached tip came out with the wire. Physician used another hawkone-s, and post dilated the sfa and popliteal arteries with an evercross 5x150 pta balloon. There is no patient injury 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 Key14248001
MDR Text Key290461718
Report Number9612164-2022-01631
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 05/17/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/29/2022
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 Number0010957355
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/10/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/25/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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