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

Model Number TH-LX-M

Device Problems Difficult to Remove (1528); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/28/2021

Event Type  malfunction  

Manufacturer Narrative

Product analysis: the turbohawk was returned coiled inside the product shelf carton.The cutter driver did not return for analysis.No ancillary devices were returned.The preliminary inspection found the distal assembly was separated at the hinge.Tip assembly was clearly separated at the hinge and the cutter is visible inside the cutter window.No damage noted to the platinum iridium coil portion of the tip assembly.Both hinge pins are visible inside the proximal end of the housing.If information is provided in the future, a supplemental report will be issued.

Event Description

Physician used a turbohawk device with a non-medtronic 7fr sheath and 6mm spider fx during treatment of a soft plaque lesion in the mid superficial femoral artery (sfa).The lesion was soft plaque.Ifu was followed.It is reported that treatment with the device was complete but during removal the packing tube detached from the catheter inside the sheath.The entire collection chamber did not detach from the device.The detachment occurred within the sheath.Moderate resistance was noted during device removal.No intervention was required and all device components were accounted for.A second turbohawk was not needed as the procedure was already completed.There was no issues noted with the spider fx.No patient injury reported.

• Brand Name: ATK TURBOHAWK SMOOTH
• Type of Device: CATHETER, 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 Key: 11581768
• MDR Text Key: 243153695
• Report Number: 9612164-2021-01215
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 00643169968424
• UDI-Public: 00643169968424
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170191
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/26/2022
• Device Model Number: TH-LX-M
• Device Catalogue Number: TH-LX-M
• Device Lot Number: 0009758182
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/27/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1