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 11/02/2018

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 hawkone m to treat a plaque lesion with 70% stenosis in the proximal right superficial femoral artery(sfa).The artery diameter and lesion length were noted as 6cm and 2cm, respectively.Physician used a non-medtronic sheath and a non-medtronic guidewire.The ifu was followed and the device was prepped without issue.The vessel was not pre-dilated.The device was used in the proximal portion of a previously deployed stent.There were no issues noted when withdrawing the device from the patient.The thumbswitch was turned off and the device was removed safely from the patient.However, it was reported that wires were observed coming out at the site of the cutting window when the device was removed from the body.The procedure was completed using 6x40 inpact admiral.No patient injury was reported.

Manufacturer Narrative

Evaluation summary: the hawkone was returned connected to a cutter driver.No other ancillary devices were included.No damages to the hawkone were observed; however a piece of metal was protruding out from the cutter window.Under microscope, the piece of metal showed characteristics similar to that of struts from a stent.The metal observed protruding out form the cutter window had a "y" shape.The metal protruding out from the cutter window is not a component of the hawkone unit.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: 8114754
• MDR Text Key: 128737229
• Report Number: 9612164-2018-03413
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 12/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/22/2021
• Device Catalogue Number: H1-M
• Device Lot Number: 0009250908
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/23/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 94