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

Model Number H1-LX

Device Problems Device Contamination with Chemical or Other Material (2944); Physical Resistance/Sticking (4012)

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

Event Date 11/20/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Physician intended to use a hawkone atherectomy device with a non-medtronic 7fr sheath and non-medtronic guidewire during treatment of a 150mm fibrous and plaque cto (chronic total occlusion-100%) in the patient¿s mid and distal right superficial femoral artery and popliteal artery. Slight vessel tortuosity and moderate calcification are reported. Artery diameter reported as 5mm. Ifu was followed. Vessel pre-dilation was not performed. Its is reported after making 2 passes the thumbswitch would not fully retract into the off position as there was plaque that would not allow for complete off position. There was no damage noted to the device cutter. The device was removed from the patient for inspection. No vessel damage was noted. A large plaque was removed from the device. Additionally, there was some wired blue coloured string like material in the cutter blade and within the flush port. It was initially though it was towel but the towel was not near when the device was removed and had not come into contact with the device. Possibly sheath lining. The procedure was then completed by pta and dcb. No patient injury reported.

• Brand Name: HAWKONE 7F
• 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: 10933729
• MDR Text Key: 219164874
• Report Number: 9612164-2020-04719
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141801
• 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: 02/10/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: H1-LX
• Device Catalogue Number: H1-LX
• Device Lot Number: 0010287165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2021
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/09/2021
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 06/23/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial