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

Model Number H1-M

Device Problem Physical Resistance/Sticking (4012)

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

Event Date 09/07/2021

Event Type  malfunction  

Event Description

Physician attempted to use a hawkone atherectomy device with a 6fr non-medtronic (terumo destination) sheath and 0.014 5mm spider fx embolic protection device during treatment of a >5cm calcified lesion in the patient's proximal left superficial femoral artery (sfa).Slight vessel tortuosity is reported.Artery diameter reported as 6mm.The patient had an arterial stent in the sfa with in-stent restenosis (isr).Ifu was followed.Vessel pre-dilation was performed.No resistance noted during advancement.Device was not passed through the stenosed stent.It is reported the hawkone plunger/packer shaft would not move.The device would not engage as the plaque was being cut.The device was unable to pack the plaque within the nosecone.No prior passes made successfully with the device.It was not possible to turn off thumbswitch.The cutter driver did not stop functioning while device was in use in patient.Device was safely removed from patient.The procedure was completed safely by opening a new hawk-m device.The procedure ended with no adverse reaction(s) to the patient.The product analysis was carried out and found that the cutter partially returned to the housing.No patient injury reported.

Manufacturer Narrative

Product analysis: the hawkone device was returned to the medtronic investigation lab for evaluation.The device was returned coiled inside four biohazard bags.The device was received with a bend on the strain relief, and the thumbswitch was fully advanced in the ¿off¿ positions.The cutter was positioned approximately 27mm inside the housing.A visual inspection found damage to the distal end of the cutter window.The cutter driver was activated and the thumbswitch was retracted to the ¿on¿ position and the cutter was able to fully return to the cutter window and rotate.No further testing could be carried out as the drive shaft broke.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 ; 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: 12802488
• MDR Text Key: 282282463
• Report Number: 9612164-2021-04385
• 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: 11/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2021
• 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: 0010673400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/05/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/10/2021
• 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 Sex: Male