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

Model Number H1-M

Device Problems Material Deformation (2976); Physical Resistance/Sticking (4012)

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

Event Date 11/05/2021

Event Type  malfunction  

Manufacturer Narrative

Product analysis: the hawkone device was returned to medtronic investigation lab for evaluation.The device was returned coiled in a biohazard bag.A visual inspection showed that the tip detached distal to the anchor pockets.The cutter returned connected to the drive shaft with no damage noted to the blade.There was no damage noted to the guidewire lumen.Image review: there were 2 images returned by the customer.Both images show the tip partially attached to the device.The cutter and distal end of the drive shaft are not in the tip and are exposed.If information is provided in the future, a supplemental report will be issued.

Event Description

Physician used a hawkone atherectomy device during treatment of a 60mm plaque cto (chronic total occlusion-100%) in the patient's mid superficial femoral artery (sfa).No vessel tortuosity or calcification reported.Artery diameter reported as 4mm.Ifu was followed.The vessel was not pre-dilated.No resistance was felt.It is reported the hawkone device would not fully pack but was housed after each attempt to pack it.It was possible to turn off the thumbswitch.Cutter driver/thumbswitch did not stop functioning while in use in patient.Cutter was just inside cutter window, would not fully pack when being removed from patient.The procedure was completed as normal. the vessel was post-dilated.Device was safely removed.When device was removed, it was noticed the tip was broken.The tip did not separate at the hinge pin.Damaged component remained attached.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: 13004085
• MDR Text Key: 285406488
• Report Number: 9612164-2021-04845
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H1-M
• Device Catalogue Number: H1-M
• Device Lot Number: 0010688884
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/20/2021
• 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: 61 YR
• Patient Sex: Female