MAUDE Adverse Event Report: MEDTRONIC IRELAND TURBOHAWK PLUS 7FR; CATHETER, PERIPHERAL, ATHERECTOMY

Catalog Number	THP-LX
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Image analysisthe customer returned one image.The image shows the housing/nosecone of a device.There is a bulge on the proximal end of the housing/nosecone.It appears that the housing wall and tecothane have been breached.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Physician was attempting to use a turbohawk plus 7f directional atherectomy device during treatment of a calcified lesion in the patients superficial femoral artery (sfa).There were no abnormalities reported in relation to anatomy.Embolic protection was not used.There was no damage noted to packaging, i.E.Shelf carton, hoop/tray.There were no issues noted when removing the device from the hoop/tray.The ifu (instruction for use) was followed during preparation, procedure, post-procedure with no issues noted.The vessel was pre-dilated.The device was not passed through a previously deployed stent.No resistance was encountered when advancing the device.A bulge in the nosecone was reported.The tecothane jacket was intact.The device was safely removed from patient.A replacement medtronic device was used to complete procedure.No patient injury reported.Image review potentially shows that the tecothane jacket may have been compromised.

• Brand Name: TURBOHAWK PLUS 7FR
• Common Device Name: 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: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 19048911
• Report Number: 9612164-2024-01616
• Device Sequence Number: 8548582
• Product Code: MCW
• UDI-Device Identifier: 00763000402358
• UDI-Public: 00763000402358
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K212027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/05/2024

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: 08/24/2025
• Device Catalogue Number: THP-LX
• Device Lot Number: 0011371927
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2024
• Initial Report FDA Received Date: 04/05/2024
• Date Device Manufactured: 08/25/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown