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

Model Number H1-M

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/25/2020

Event Type  malfunction  

Manufacturer Narrative

Image review: one cine image was returned for review.The cutter, proximal end of the housing assembly, flush mouth and rotating distal tip were observed in the cine image.A bend was noted in the housing assembly, near the location of the cutter.Product analysis: the device was returned within a white saftpak envelope.Within the envelope, the device was contained within a sealed biohazard package.No ancillary devices were received.The device was removed from the return packaging.The cutter driver was returned attached to the hawkone catheter.A slight bend was noted in the torque shaft, beneath the strain relief.Inspection of the distal assembly revealed biological debris through the housing assembly.A bend was noted in the housing just distal to the cutter window.A hole was noted at the bend.The cutter was seen protruding out of the hole within the housing and tecothane.The cutter remained attached to the drive shaft.No anomalies were noted with the guidewire lumen.Microscopic inspection was performed.No anomalies were noted with the cutter window of the device.It was observed that the proximal portion of the housing assembly had detached from the cutter window assembly.The housing tecothane coating had moved proximally along the cutter window.Bending and separation of the inner laser drilled coils of the housing assembly was also noted.The hole in the housing assembly, near the proximal end, was likely due to the interaction of the cutter with tecothane coating.No anomalies were noted with the cutter.If information is provided in the future, a supplemental report will be issued.

Event Description

Physician was attempting to use a hawkone directional atherectomy along with a non-medtronic 7fr sheath, spider fx guide wire and embolic protection during procedure to treat a none calcified soft tissue lesion in the right proximal superficial femoral artery (sfa) with 95% stenosis.The vessel was little tortuous.The vessel diameter and lesion length were 6mm and 60mm respectively.The vessel was not pre dilated but post dilated.Ifu was followed.There was no difficulties when advancing the device through the lesion.It was reported that physician had made one pass, removed to clean device, reinserted and upon making a couple of cuts device appeared to have a bend at cutter window and would not pack well.The issue occurred when trying to cut the device off, where the difficulty was getting the device cutter to go back into the cutter housing.The physician held their finger on the thumbswitch and flipped power off on the battery.It is unknown where was the position of the cutter in relation to the nosecone during the device removal from the patient.The cutter was able to go back into the housing outside of the patient's body.The device was safely removed from the patient.There was deformation noticed in the cutter.No pieces of the cutter were noticed to be missing.Another hawkone device was used to complete the procedure.There was no patient injury reported.

• Brand Name: HAWKONE 6FR
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; IE
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; IE
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; IE ; 091708734
• MDR Report Key: 10834717
• MDR Text Key: 219351841
• Report Number: 9612164-2020-04404
• 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
• Report Date: 11/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/26/2023
• Device Model Number: H1-M
• Device Catalogue Number: H1-M
• Device Lot Number: 0010155373
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/13/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/27/2020
• 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: 68 YR
• Patient Weight: 95