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

Model Number THP-M

Device Problems Detachment of Device or Device Component (2907); Difficult to Advance (2920)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/08/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Physician was attempting to use a turbohawk plus directional atherectomy along with non-medtronic 6fr sheath and spider fx guidewire during procedure to treat to treat a severely calcified lesion in the mid superficial femoral artery (sfa) with unknown percentage stenosis. The vessel was little tortuous. The device was inspected with no issues noted. The device was prepped per ifu with no issues identified. It was reported that the wire prolapsed and the tip ended up becoming detached inside the destination sheath 6f. At that time the tip of the turbohawk plus was pulled back into the sheath and got stuck. The tip of the turbohawk plus then became detached while inside the 6f ansel sheath. The physician removed everything at this point (sheath, hawk, sider) in its entirety. Physician then gained access again and completed imaging to ensure no issues. There was no vessel damage. After gaining access again with a new sheath, angioplasty was done to the sfa and procedure was completed as normal with a closure device. There was no patient in jury reported.

• Brand Name: TURBOHAWK PLUS 6FR
• 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: 14014979
• MDR Text Key: 288609733
• Report Number: 9612164-2022-01329
• 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

• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 04/05/2022

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 04/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: THP-M
• Device Catalogue Number: THP-M
• Device Lot Number: 0010819446
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2022
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 08/26/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0694-2022