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

Catalog Number H1-M

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/30/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The physician attempted to use a hawkone directional atherectomy catheter and a 6mm spider filter guidewire to treat a 300mm fibrous cto (chronic total occlusion-100%) with little calcification in the right superficial femoral artery. The artery had a 6mm diameter and had little tortuosity. The procedure used a 6 fr non-mdt sheath. The vessel was pre and post dilated. The devices were prepped as per the ifu and the guidewire was hydrated during prep. It was reported that severe resistance was encountered advancing the device. The device was advanced over bifurcation. The guidewire locked up on the hawkone and the wire separated through the side of the device tip. Tip damage was reported on the hawkone. The device was removed by pulling the guidewire from the lumen with resistance. It was further reported the device was loaded correctly while advancing the wire separated from the device. No detachment occurred. The tecothane jacket is reported to have torn. The procedure was completed using a drug coated balloon. No patient complications have been reported as a result of this event.

Manufacturer Narrative

The hawkone was returned connected to a cutter driver. No ancillary devices were included. The hawkone was visually inspected and it was noted that the guidewire tubing was damaged. The guidewire lumen of the rotating tip showed that the proximal end was buckled and pointed upwards from the tip. A yellow/green debris was observed between the rotating tip lumen and the housing lumen. The debris was likely ptfe from the capture wire of the spider fx. The guidewire tubing of the housing segment showed a zipper tear throughout the segment. It was discovered the yellow/green debris was observed on the outside of the torque shaft adapter. The drive shaft was bent at an approximate 90 degree bend at the strain relief. No other damages to the hawkone was observed. Functional testing was performed and a 0. 014" guidewire from the lab was front-loaded. The guidewire entered the tip, but was protruding out from the beginning of the tear. The guidewire was back-loaded and the tear was evident throughout the segment. The guidewire could not be loaded. If information is provided in the future, a supplemental report will be issued.

• Brand Name: HAWKONE 6FR
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 8124903
• Report Number: 9612164-2018-03450
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 00643169968332
• UDI-Public: 00643169968332
• 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,Followup
• Report Date: 01/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 08/23/2021
• Device Catalogue Number: H1-M
• Device Lot Number: 0009295323
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2018
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Age: 69 YR
• Patient Weight: 66