MAUDE Adverse Event Report: MEDTRONIC IRELAND ATK TURBOHAWK CALCIUM CATHETER, PERIPHERAL, ATHERECTOMY

Model Number THS-LX-C

Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907); Difficult to Advance (2920)

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

Event Date 01/07/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Physician intended to use a turbohawk atherectomy device with a spider fx embolic protection device and 7fr non-medtronic sheath during treatment of a plaque and soft tissue lesion in the patient's superficial femoral artery (sfa). Moderate vessel tortuosity and slight calcification are reported. Ifu was followed and the devices were prepped without issue. It is reported resistance was noted during advancement of the devices and it is reported the nosecone detached from the driveshaft of the turbohawk device. The spider fx is reported to have become damage during withdrawal. The devices were removed and replaced to complete the procedure. No patient injury reported.

• Brand Name: ATK TURBOHAWK CALCIUM
• 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: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 11163266
• MDR Text Key: 226566328
• Report Number: 9612164-2021-00157
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170191
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/09/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 01/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 02/13/2022
• Device Model Number: THS-LX-C
• Device Catalogue Number: THS-LX-C
• Device Lot Number: 0009592930
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2021
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/24/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/14/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage