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

Model Number H1-M

Device Problems Device Damaged by Another Device (2915); Material Split, Cut or Torn (4008)

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

Event Date 12/28/2020

Event Type  malfunction  

Manufacturer Narrative

Product analysis: the hawkone device was received loosely in a double sealed biohazard bag within a safe pack biohazard tyvek pouch. The lot number was verified on the outer product label and confirmed as 0010386420. Device returned with detached tip assembly and device connected to the cutter driver. Visual inspection confirms that the detachment site occurred distal to the anchor pockets with the cutter visible at the end of the drive shaft. No anomalies noted with the cutter. Device returned with thumbswitch in off position and the power switched on. Detachment site visible distal to the anchor pockets and the cutter attached to the drive shaft. Detachment site visible at the proximal end of the tip assembly with bunching and deformation noted to the guidewire lumen at the proximal end. A 0. 014¿ guidewire from the lab was unable to be loaded via the distal to due to biologics present. After soaking the tip assembly in a water bath for a few hours the guidewire was then able to be loaded without issues. If information is provided in the future, a supplemental report will be issued.

Event Description

Physician intended to use a hawkone atherectomy device with a non-medtronic 6fr sheath and non-medtronic 0. 014 guidewire during trea tment of a 5cm calcified lesion in the patient¿s distal right popliteal artery and tibial/popliteal trunk. Artery diameter reported as 5mm. Moderate vessel tortuosity and severe calcification reported. Lesion exhibited 80% stenosis. Ifu was followed. The device was advanced over the bifurcation. It is reported the tip of the device was damaged during the procedure. The guidewire lumen was reported to be torn from the distal tip. The guidewire did not lock-up on the catheter. It is reported everything was safely removed from the patient and access point was closed. New access was gained on antegrade side to complete the procedure. No patient injury reported.

• Brand Name: HAWKONE 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: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 11524114
• MDR Text Key: 242669415
• Report Number: 9612164-2021-01037
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial
• Report Date: 03/19/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 03/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: H1-M
• Device Catalogue Number: H1-M
• Device Lot Number: 0010386420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2021
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/22/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial