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

Model Number THP-LX

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Perforation (2001); Vascular Dissection (3160)

Event Date 02/07/2022

Event Type  Injury  

Event Description

Physician was attempting to use the turbohawk plus atherectomy device during procedure to treat lesion in the mid superficial femoral artery (sfa). The vessel had no tortuosity. The device was inspected with no issues noted. The device was prepped per the ifu was no issues identified. It was reported that vessel damage/injury occurred. It was reported that dissection/perforation occurred. No issue with turbohawk device during use. Unknown if device contributed to the vessel dissection/perforation/injury. No resistance encountered during advancement/withdrawal of the device. Device was safely removed from patient. A covered stent was used to fix the issue. No further patient injury reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: TURBOHAWK PLUS 7FR
• Type of Device: 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: 13618746
• MDR Text Key: 286236815
• Report Number: 9612164-2022-00817
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K212027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 03/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: THP-LX
• Device Catalogue Number: THP-LX
• Device Lot Number: 0010772877
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/09/2022
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 07/21/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 02/28/2022 Patient Sequence Number: 1