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U.S. Department of Health and Human Services

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

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MEDTRONIC IRELAND ATK TURBOHAWK CALCIUM CATHETER, PERIPHERAL, ATHERECTOMY Back to Search Results
Model Number THS-LX-C
Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907); Difficult to Advance (2920)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/07/2021
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Physician intended to use a turbohawk atherectomy device with a spider fx embolic protection device and 7fr non-medtronic sheath during treatment of a plaque and soft tissue lesion in the patient's superficial femoral artery (sfa). Moderate vessel tortuosity and slight calcification are reported. Ifu was followed and the devices were prepped without issue. It is reported resistance was noted during advancement of the devices and it is reported the nosecone detached from the driveshaft of the turbohawk device. The spider fx is reported to have become damage during withdrawal. The devices were removed and replaced to complete the procedure. No patient injury reported.
 
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Brand NameATK TURBOHAWK CALCIUM
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
toni o'doherty
parkmore business park west
galway 
EI  
091708734
MDR Report Key11163266
MDR Text Key226566328
Report Number9612164-2021-00157
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K170191
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 04/09/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/13/2022
Device Model NumberTHS-LX-C
Device Catalogue NumberTHS-LX-C
Device Lot Number0009592930
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/19/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/24/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/14/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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