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

Model Number	TH-LX-M
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	03/22/2021
Type of Reportable Event	Serious Injury
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 during treatment of a calcified lesion in the patient¿s distal superficial femoral artery (sfa).Slight vessel calcification and tortuosity are reported.Lesion exhibited 80% stenosis.Ifu was followed.Vessel pre-dilation was performed.Resistance was noted during advancement.It is reported during the procedure the cutter was damaged.Collection tube detached and required retrieval from the patient using a snare.A replacement turbohawk device was used to complete the procedure.The vessel was post-dilated.No further injury reported.
Additional Manufacturer Narrative
Device evaluation visual inspection under a microscope confirms damage to the cutter and proximal end of the metal housing.A 0.014¿ guidewire from the lab was loaded via the distal tip and exited at the proximal end of the housing with no difficulty.No damage noted to the guidewire lumen or metal housing.No biologics present in 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.

• 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: 11617704
• Report Number: 9612164-2021-01310
• Device Sequence Number: 17234522
• 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
• 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): 05/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/25/2022
• Device Model Number: TH-LX-M
• Device Catalogue Number: TH-LX-M
• Device Lot Number: 0010032751
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2021
• Initial Date Received by Manufacturer: 03/22/2021
• Supplement Date Received by Manufacturer: 05/07/2021
• Initial Report FDA Received Date: 04/06/2021
• Supplement Report FDA Received Date: 05/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Weight: 56