MAUDE Adverse Event Report: MEDTRONIC IRELAND HAWKONE 7F; CATHETER, PERIPHERAL, ATHERECTOMY

Model Number	H1-LX
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation visual inspection of the tip shows the spider fx wire within the hawk device and damage noted to the distal tip the device returned with damage noted to the strain relief.Visual inspection under a microscope shows stretching to the metal coils at the proximal end of the housing.The plastic pet material around the housing is detached from the anchor pockets and lots of biologics is visible inside the housing.The guidewire lumen is damaged and detached from the proximal end of the housing to the middle of the housing.Damage is noted to the hawkone distal assembly and the spider fx wire is noted entering the distal tip and exiting the proximal end of the nosecone with part of the gw lumen wrapped around the spider wire.Biologics are visible on the nosecone.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Physician attempted to use a hawkone atherectomy device with a 7fr non-medtronic (cordis brite tip) sheath and 5mm spider fx embolic protection device during treatment of a plaque cto (chronic total occlusion-100%) in the patient¿s mid superficial femoral artery (sfa).Slight vessel tortuosity and calcification are reported.Ifu was followed.The guidewire was hydrated at preparation.The device was advanced over the bifurcation.It is reported severe resistance was noted during withdrawal and the tip of the device became damaged.The guidewire lumen was not torn from the distal tip and the guidewire did not lock up on the catheter.Everything was removed from the patient through the access site.The sheath was removed followed by the hawk over the spider wire and lastly the spider basket.There was no issues noted with the spider fx.No components detached from the device.The procedure was completed by the removal of the devices from the patient.No patient injury reported.When the device was retuned for evaluation, it was noted that the guidewire lumen was damaged and detached.

• Brand Name: HAWKONE 7F
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• MDR Report Key: 12413235
• Report Number: 9612164-2021-03397
• Device Sequence Number: 3738553
• Product Code: MCW
• UDI-Device Identifier: 00643169968509
• UDI-Public: 00643169968509
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K141801
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/02/2023
• Device Model Number: H1-LX
• Device Catalogue Number: H1-LX
• Device Lot Number: 0010477108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2021
• Initial Report FDA Received Date: 09/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1