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

Model Number	TH-LX-M
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2021
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 was attempting to use a turbohawk directional atherectomy during procedure to treat a plaque lesion in the mid superficial femoral artery (sfa).The device was inspected with no issues noted.The device was prepped per ifu with no issues identified.It was reported that the device jammed and will not close.The cutter driver was inside the housing unit when crash occurred.It was possible to turn off the thumbswitch.The cutter driver/thumbswitch did not stop functioning while in use in patient.Cutter driver was exposed relative to the nosecone when removed from patient.Device was safely removed from patient.No deformation noticed in cutter.There was no patient injury.
Additional Manufacturer Narrative
Device evaluation the cutter returned inside the cutter window with plaque inside the window.An attempt was made to advance the cutter into the housing; however, it was not possible due to the amount of plaque present.During visual inspection, a bulge was noted on the metal housing at approx.11mm distal from the cutter window.No damage noted to the distal tip of the device.The device was soaked in a waterbath overnight and some plaque was removed, however a large amount of plaque remained inside the window and housing which prevented the cutter from advancing into the housing 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: 11634895
• Report Number: 9612164-2021-01373
• Device Sequence Number: 3496150
• Product Code: MCW
• UDI-Device Identifier: 00643169968424
• UDI-Public: 00643169968424
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K170191
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2021

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: 11/04/2023
• Device Model Number: TH-LX-M
• Device Catalogue Number: TH-LX-M
• Device Lot Number: 0010441970
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2021
• Initial Date Received by Manufacturer: 03/15/2021
• Supplement Date Received by Manufacturer: 05/14/2021
• Initial Report FDA Received Date: 04/08/2021
• Supplement Report FDA Received Date: 05/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR