MAUDE Adverse Event Report: COVIDIEN (IRVINE) HAWKONE 6FR; CATHETER, PERIPHERAL, ATHERECTOMY

Catalog Number	H1-M
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Physician used a hawkone directional atherectomy device with a 6fr sheath and.014 guidewire for the treatment of a 30 mm slightly calcified; non-tortuous plaque lesion in the right mid superficial femoral artery (sfa) of diameter 6 mm.Lesion exhibited 80% stenosis.Device ifu was followed.The vessel was not pre-dilated.Moderate resistance was felt during withdrawal of the device.It was reported that upon trying to remove the hawkone device, the wire tore through the wire channel and when device was removed through the sheath, the tip broke off.It was reported the guidewire prolapse caused the tip damage to occur.The tip detached in the sfa just outside the sheath.No injuries to the patient occurred.The area was stented to complete the procedure.
Additional Manufacturer Narrative
Device evaluation summary: the hawkone was received in two pieces.The first analyzed piece was the distal assembly which was fractured and separated approximately 2mm distal the cutter window.The segment showed the guidewire tubing frayed and disengaged from the proximal end of the segment.The total length of the distal assembly segment was approximately 6cm.The distal segment was inspected under microscope.The fracture face showed a radial tear to the tecothane and the laser drilled coils were stretched proximal out from the tecothane.The guidewire tubing was torn out and disengaged from the proximal.As the guidewire tubing was inspected distally the tubing was more visible and showed signs of zipper tearing.The tearing continued throughout the entire segment of the guidewire tubing of the laser drilled coils segment.Damage to the proximal end of the guidewire tubing segment was noted to the rotating tip, but remained engaged.It should be noted traces of a green debris was noted within the guidewire tubing and between the rotating tip and the laser drilled coil segment.The laser drilled coils were flattened approximately 1cm from the flush mouth of the distal assembly.The second piece was inspected which included the remaining portion of the hawkone with the cutter driver attached.The drive shaft was exposed with the cutter assembly attached outside of the cutter window.The radial fracture occurred approximately 0.2cm distal the cutter window.Red dried biological debris was noted within the cutter window.All components of the hawkone were accounted for.There was no indication any portions/components of the hawkone were not returned.If information is provided in the future, a supplemental report will be issued.

• Brand Name: HAWKONE 6FR
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• MDR Report Key: 6755951
• Report Number: 2183870-2017-00322
• Device Sequence Number: 130577
• Product Code: MCW
• UDI-Device Identifier: 00643169792302
• UDI-Public: 00643169792302
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K161361
• 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
• Report Date (Section B): 12/14/2017

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: 05/17/2020
• Device Catalogue Number: H1-M
• Device Lot Number: A462061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2017
• Initial Date Received by Manufacturer: 07/03/2017
• Supplement Date Received by Manufacturer: 07/03/2017
• Initial Report FDA Received Date: 07/31/2017
• Supplement Report FDA Received Date: 12/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1