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

Model Number	TH-LX-M
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Physician attempted to use a turbohawk atherectomy device with a 6fr sheath and 0.014 non-medtronic guidewire during a procedure to treat a 40mm lesion in the patient¿s mid right popliteal artery.Moderate vessel tortuosity and severe calcification are reported.Lesion exhibited 90% stenosis.Artery diameter reported as 5mm.It is reported that the pop was extremely calcified.Vessel pre-dilation was performed.It is reported that severe resistance was noted during initial advancement of the device and it was unable to cross the lesion.During withdrawal, severe resistance was felt, and it is reported that tip damage occurred.It is reported that the nosecone fell apart when the doctor was flushing the device for the second time.This did not occur in the patient.The physician used a non-medtronic 3x40 to cross the lesion followed by a 5x40 non-medtronic balloon to complete the procedure.No patient injury reported.
Additional Manufacturer Narrative
Device evaluation visual inspection noted the detached nosecone as received with the centre flattened.The detachment site on the catheter shaft is seen with the cutter attached to the drive shaft.Under the microscope there is no deformation noted to the cutter.The detachment site is visible under a microscope just proximal to the anchor pockets.No functional testing could be carried out due to the condition of the returned device.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ATK TURBOHAWK SMOOTH
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• MDR Report Key: 11434864
• Report Number: 9612164-2021-00902
• Device Sequence Number: 14630464
• Product Code: MCW
• UDI-Device Identifier: 00643169968424
• UDI-Public: 00643169968424
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K170191
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/26/2023
• Device Model Number: TH-LX-M
• Device Catalogue Number: TH-LX-M
• Device Lot Number: 0010471378
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2021
• Initial Date Received by Manufacturer: 03/02/2021
• Supplement Date Received by Manufacturer: 04/28/2021
• Initial Report FDA Received Date: 03/08/2021
• Supplement Report FDA Received Date: 04/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1