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

Catalog Number H1-M

Device Problem Material Fragmentation (1261)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 10/02/2018

Event Type  Injury  

Manufacturer Narrative

The hawkone was not received for evaluation.No ancillary devices from the procedure were received.Five photographic images were received for evaluation.The photographic images included three procedure related cine images.The first photographic image is of the h1-m cutter.The cutter head and drive shaft are exposed distal of the cutter window.The tecothane coated distal coil assembly and distal tip are not present.The separation face is just distal of the cutter window.The second image is of a cine image.In the image tecothane coated distal coil assembly and distal tip are present just distal of support sheath.The distal tip of assembly remains on 0.014¿ guidewire.The third image is of a cine image.In the image tecothane coated distal coil assembly/distal tip are present just distal of support sheath and are in the process of being snared.The distal tip of assembly remains on 0.014¿ guidewire but the guidewire lumen appears to be torn from the distal assembly coil section.The fourth image is of the snare recovered distal assembly next to the h1-m cutter.The fifth image is of a stent with a radiopaque artifact being pointed to among the stent struts.If information is provided in the future, a supplemental report will be issued.

Event Description

The physician was attempting to use a hawkone to treat a moderately calcified lesion with (chronic total occlusion - 100%) in the distal tibial/popliteal trunk.Physician used a 7fr sheath and a 0.014 guidewire.Ifu was followed and the device was prepped without issue.It was reported that there was moderate resistance felt during withdrawal and the tip separated at the hinge pin.The physician reported after he finished making cuts he was taking the catheter out and when it got to the sheath the physician felt resistance and pulled fairly hard.When he removed the device he noticed that there was no tip and it was sitting just outside the sheath.After removing the device the cutter was removed using a snare.A very small piece of the cutter could not be removed and remained in the artery.The physician stented over this piece to tack the remaining portion to the vessel wall.No injury to the patient was reported.

Manufacturer Narrative

The hawkone was returned for evaluation.The cutter driver was connected to the hawkone.No other ancillary devices were included.A visual inspection of the hawkone was completed.It was discovered the hawkone was returned in two separate segments.The coiled housing showed a radial fracture at location where the laser drilled coils are initiate at the proximal end.The thumb switch was in the forward position, which showed the drive shaft and cuter assembly exposed outside from the proximal fracture face of the housing assembly.The distal segment of the hawkone which fractured off was inspected.The total length of the segment was approximately 6cm.It was noted the proximal fracture face showed the laser drilled coils stretched out proximally within the tecothane layer of the distal assembly.The tecothane layer showed a rounded smooth surface.The guidewire tubing torn/peeled out at the proximal end flapped over.Zipper tearing of the guidewire tubing was noted.No damage to the rotating tip guidewire lumen was observed.The proximal segment of the hawkone was inspected.The exposed drive shaft and cutter assembly showed no damages.The radial fracture of the housing was identified at the location where the coils initiate distal the vent holes of the housing.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
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 8023300
• MDR Text Key: 125601108
• Report Number: 9612164-2018-02995
• 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: K141801
• 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,Followup
• Report Date: 12/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/22/2021
• Device Catalogue Number: H1-M
• Device Lot Number: 0009250909
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/27/2018
• Date Device Manufactured: 07/23/2018
• 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 Outcome(s): Required Intervention