MAUDE Adverse Event Report: MEDTRONIC IRELAND TURBOHAWK PLUS 6FR; CATHETER, PERIPHERAL, ATHERECTOMY

Catalog Number	THP-S
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 s directional atherectomy along with a 6fr non-medtronic sheath and a 300cm 0.014 n on-medtronic guidewire during treatment of a fibrous plaque lesion in the patients left mid superficial femoral artery (sfa).Artery diameter reported as 7mm.Lesion exhibited 80% stenosis.There were no abnormalities reported in relation to anatomy.Embolic prote action 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 without issue.The vessel was pre-dilated.The vessel was post-dilated with an evercross pta balloon.The device was not passed through a previously deployed stent.No resistance was encountered when advancing the device.It was reported the nosecone separated from drive shaft in the patients vessel.The detached component was removed within the sheath.The device was safely removed from the patient.Procedure was aborted.There was no patient injury/intervention associated with this event.
Additional Manufacturer Narrative
Product analysis a visual inspection showed that the tip/housing detached at the hinge pins.The hinge pins are still attached to the device, the reported event that the tip detached can be confirmed based on the condition of the returned device.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.

• Brand Name: TURBOHAWK PLUS 6FR
• 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: 18948727
• Report Number: 9612164-2024-01373
• Device Sequence Number: 15445153
• Product Code: MCW
• UDI-Device Identifier: 00763000402419
• UDI-Public: 00763000402419
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2024

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: 08/20/2026
• Device Catalogue Number: THP-S
• Device Lot Number: 0011918502
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2024
• Supplement Date Received by Manufacturer: 04/19/2024
• Initial Report FDA Received Date: 03/21/2024
• Supplement Report FDA Received Date: 04/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/21/2023
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0695-2022
• Patient Sequence Number: 1
• Patient Sex: Male