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

Catalog Number H1-M

Device Problems Failure to Power Up (1476); Device Remains Activated (1525); Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/21/2018

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 to treat plaque in the proximal superficial femoral artery physician used a non-medtronic 6fr sheath and 0.014 non medtronic guidewire.Ifu was followed and the device was prepped without issue.It was reported that during the procedure the device was advanced into sheath.When attempt was made to engage cutter, it was noted that device would not turn on.Device was removed intact and a fracture was noticed just distal to the cutter.The blade did not return to the housing after removal and remained in a open cutting position.The procedure was completed using a new device.No patient injury reported.

Manufacturer Narrative

Device evaluation: the hawkone was received still attached to its cutter driver unit.The distal assembly was received torsional damage just distal of the cutter window, with the tecothane coating also damaged.The cutter head remains within the distal coil section of the distal assembly.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: 8037042
• MDR Text Key: 126178094
• Report Number: 9612164-2018-03050
• 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: 04/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/15/2021
• Device Catalogue Number: H1-M
• Device Lot Number: 0009282091
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/17/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/16/2018
• 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