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); Physical Resistance/Sticking (4012)

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

Event Date 04/01/2022

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 during procedure along with non-medtronic 6fr sheath and 0. 014" guidewire during procedure to treat a moderately calcified soft tissue lesion in the right mid superficial femoral artery (sfa) and popliteal artery (pop) with 60% stenosis. The vessel was moderately tortuous. The vessel diameter and lesion length are 5mm and 40mm respectively. The vessel was not pre dilated but post dilated. Ifu was followed. Tip detachment/damage occurred with a moderate resistance felt during advancement. The tip did not separate at the hinge pin. It was reported that after the first pass/cut was made with the turbohawk, when tech pulled thumb switch back to turn off device, it did not want to completely shut off. Therefore, the tech proceeded to turn off the battery pack and the device was removed. The physician did not want to waste time and asked for the device to be put in a biohazard bag. A hawkone was then attempted to continue procedure, and it was reported that when advancing the hawkone-s, physician felt a lot of resistance, after getting it through the sheath, the device performed well. When removing the device, physician felt event more resistance than when advancing it. The catheter came out without the nosecone. The nosecone stayed stuck in the proximal end of the sheath. Physician continued to remove wire, while thinking of removing the entire sheath, but then the detached tip came out with the wire. Physician used another hawkone-s, and post dilated the sfa and popliteal arteries with an evercross 5x150 pta balloon. There is no patient injury 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: 14248001
• MDR Text Key: 290461718
• Report Number: 9612164-2022-01631
• 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: 05/17/2022

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 04/29/2022
• 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: 0010957355
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/10/2022
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 11/25/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial