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

Catalog Number H1-M

Device Problems Device Operates Differently Than Expected (2913); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/13/2018

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: the hawkone was returned with the cutter driver attached.A green 0.014" guidewire was loaded the distal assembly of the hawkone.No other ancillary devices were included.The green guidewire was removed from the hawkone and inspected.A bend was observed approximately 215cm from the stiff end of the guidewire.The total length of the guidewire was approximately 300cm.Under microscope the green coating of the guidewire appeared skived off from the wire at the area of the bend.The hawkone was inspected.The cutter was advanced approximately 1.6cm distal the cutter window.Biological debris was observed with the coil segment, in front and behind the cutter.The area of the cutter window was bent.The damage was consistent with coil assembly being compressed in one direction.Traces of green coating were observed on the hawkone, primarily on top of the torque shaft adapter.No damages to the distal tip or guidewire tubing of the hawkone were observed.The cutter driver power switch was placed to the on position.However the cutter driver would not activate once the thumb switch was pulled back.The cutter driver was detached and connected to a cutter driver from the lab.The cutter was able to retract back into the cutter window.No damage to the cutter assembly was noted, but debris was observed on the cutter head.The thumb switch was advanced; however the cutter was unable to advance past the cutter window.If information is provided in the future, a supplemental report will be issued.

Event Description

The physician used the hawkone 6f with a 7f sheath and non-medtronic 0.014 guidewire to treat the right mid/distal superficial femoral artery and popliteal artery, with a severely calcified cto as per the ifu, the lesion has little tortuosity.Artery diameter was 4mm, lesion length was 150mm.The ifu was followed during preparation, procedure and post procedure.The vessel was pre-dilated.Resistance was not felt during advancement.It was reported after the first round of cutting, the tech cleaned the cone, the hawkone was advanced for a second round of cutting along the length of the lesion with difficulty encountered.It was observed under fluoroscopy that the plunger would not return back, the physician turned the device on and off several times to no effect.The cutter returned to the housing before the device was removed from the patient.A broken flush port and cutter damage is reported, all device components removed from the patient.The procedure was completed using a turbohawk lx-c with good results reported.No patient injury was reported.

• Brand Name: HAWKONE 6FR
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 7506807
• MDR Text Key: 107996001
• Report Number: 9612164-2018-01053
• 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: 05/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/12/2021
• Device Catalogue Number: H1-M
• Device Lot Number: 0008993871
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/13/2018
• 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: 55 YR
• Patient Weight: 59