MAUDE Adverse Event Report: COVIDIEN (IRVINE) HAWKONE 7F; CATHETER, PERIPHERAL, ATHERECTOMY

Catalog Number	H1-LS
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	06/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The hawkone was not received for evaluation.No ancillary devices from the procedure were received.Three photographic images were received.Image analysis: the first image is a collage that includes two cine images, a section of the shelf carton label, and a surgical drape/towel with debris removed from the hawkone directional atherectomy system along with a 3-ml syringe.The cine images are of contrast flow through the targeted vessel anatomy (right superficial femoral artery).The image appears to show pre-treatment and the vessel which has little tortuosity and a moderately calcified fibrous lesion.It also shows post-treatment with a guidewire visibly running through the targeted vessel.There is a reduction in size of the moderately calcified fibrous lesion.The surgical drape has three rows of debris along with a 3-ml syringe.The debris appears to fibrous and includes some calcified debris.The second image is a cine distal of the prior two cine images.There is no guidewire in the image.The vessel shows a degree of tortuosity and a fibrous lesion with calcification.The image is most likely pre-treatment.The third image is a collage that includes two cine images, a section of the shelf carton label, and a surgical drape/towel with debris removed from the hawkone directional atherectomy system along with a 3-ml syringe.The shelf carton label carton label, and a surgical drape/towel with debris are identical to the first image collage.The cine images are different in the second collage.The cine images are of contrast flow through the targeted vessel.The cine image on the left side is pre-treatment and appears to be a duplicate of the second image.The cine image on the right side is post-treatment with a guidewire running through the targeted vessel if information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician was attempting to use a hawkone directional atherectomy catheter to treat a moderately calcified fibrous lesion in the right proximal/distal superficial femoral artery.The vessel had little tortuosity.The lesion had resulted in 60% stenosis in the vessel.The device was prepped as per the ifu with no issues identified.While trying to turn off device and pack the nose cone the device jammed and would not close.The device would turn off but the cutter would not advance into the nosecone.The cutter was outside the housing in the cutting position when it stopped functioning inside the patient.Multiple attempts were made to pack device and advance cutter into nose cone.Eventually the thumb switch advanced forward but the blade/ packer did not move.It was reported a metal rod bowed up in front of thumb switch.No deformation was noted to the cutter.The device was safely removed and inspected.The device was no longer functional and switched devices to complete case.
Additional Manufacturer Narrative
The hawkone was returned for evaluation with no cutter driver connected.No ancillary devices were included.Visual inspection of the device was completed.The thumb switch was retracted and the cutter was positioned within the cutter window.An unknown debris behind the cutter rim was noted.The material could be calcified debris from the lesion with traces of blue/green contrast or if the debris was from wiping the distal assembly after the device was removed from the patient.Biological debris was noted at the distal segment of the housing at the flush mouth of the distal assembly.Blue thread was noted sticking to the outside of the torque shaft, likely from a cloth used to wipe the device down post-procedure.The hypotube was protruding out from the slider cover and was bent upward and back down into the slider cover.Within the slider cover it was observed the hypotube and drive shaft were fractured apart.A tweezers from the lab was used to take pry out the distal end of the hypotube.The fracture face of both segments showed the characteristics of a ductile type fracture under microscope.The hypotube and drive shaft showed signs of twisting and exposure to excessive tensile forces.During functional testing, the thumb switch was advanced and the cutter did not change positions and remained nested within the cutter window.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: HAWKONE 7F
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• MDR Report Key: 7705908
• Report Number: 2183870-2018-00387
• Device Sequence Number: 1328880
• Product Code: MCW
• UDI-Device Identifier: 00821684057926
• UDI-Public: 00821684057926
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K141801
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/08/2019
• Device Catalogue Number: H1-LS
• Device Lot Number: A372426
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2018
• Initial Date Received by Manufacturer: 06/22/2018
• Supplement Date Received by Manufacturer: 08/21/2018; 08/08/2018
• Initial Report FDA Received Date: 07/20/2018
• Supplement Report FDA Received Date: 09/18/2018; 10/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 83 YR