• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDTRONIC IRELAND ATK TURBOHAWK SMOOTH CATHETER, PERIPHERAL, ATHERECTOMY Back to Search Results
Model Number TH-LX-M
Device Problems Entrapment of Device (1212); Difficult to Remove (1528)
Patient Problem Vascular Dissection (3160)
Event Date 04/06/2022
Event Type  Injury  
Event Description
Physician was attempting to use the hawkone atherectomy device during procedure to treat moderately calcified fibrous plaque in the distal right superficial femoral artery (sfa) with chronic total occlusion (cto -100%). The vessel had moderately tortuous. The vessel diameter and lesion length was 5mm and 13mm respectively. The device was inspected and prepped per ifu with no issues identified. It was reported that during the surgery, the physician first used a 2mm balloon to pre-dilate the target lesion vessel of the sfa, then the distal popliteal artery was protected with a 4mm spider. The hawk cutter head was flushed according to standard procedure,exchanged and then delivered to the target lesion vessel. Following the vascular 3 o'clock direction, rotation cut from the proximal of the blood vessel to the distal end. Pushed the push rod of the recovery bin to the front. At this time, the physician was ready to withdraw the blade to check the rotary cutting situation. It was found that during the withdrawal process, the distal spider retreated with the rotary blade. After repeated attempts,  it still could not be solved. Finally, the blade was withdrawn relatively vigorously. After the spider retracted to the proximal of the popliteal artery, it separated from the blade. The blade was withdrawn, for the safety, the physician chose a non-medtronic balloon after dilation for dcb treatment. Due to vascular flow-restricting dissection, physician placed a salvage stent, a 5x150 everflex stent. It is unknown which device (spider or hawk) caused the dissection. Tissue found in spider body after the surgery. The patient has been discharged from hospital. No further patient injury.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key14111378
MDR Text Key289261650
Report Number9612164-2022-01456
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K111723
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 04/14/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/14/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberTH-LX-M
Device Catalogue NumberTH-LX-M
Device Lot Number0010641801
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/06/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/14/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 04/14/2022 Patient Sequence Number: 1
-
-