MAUDE Adverse Event Report: COVIDIEN 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	02/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The hawkone was not received for evaluation.No ancillary devices or cine images from the procedure were received.A single photographic image was received.The photographic image shows the hawkone cutter separated just distal of the distal assembly cutter window.A tearing of the distal assembly just distal of the cutter window was observed.The coil housing, flushing port, and distal tip remain on the guidewire that protrudes from the support catheter.The cutter head and drive shaft extend distally from the cutter window.Due to the quality, clarity, and pixelation of the photographic image it is not possible to confirm or not confirm if the guidewire prolapsed.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Physician employed the use of a hawkone device with 6fr non-mdt sheath and 7mm spider fx embolic protection device for the treatment of a severely calcified 40mm lesion in the proximal right superficial femoral artery (sfa) of diameter 7mm.Lesion exhibited 80% stenosis.Vessel reported to be severely tortuous.Vessel was not pre-dilated.Ifu was followed.It is reported during withdrawal of the device severe resistance was experienced and the tip detached at the hinge pin (separation occurred from the cutter and nose cone).The entire system was removed from the patient with no intervention required nor injury to the patient.The cutter was reported to have been outside the housing during removal but was removed safely.The patient has been discharged.

• Brand Name: HAWKONE 6FR
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): COVIDIEN; 9775 toledo way; irvine CA 92618
• MDR Report Key: 7308836
• Report Number: 9612164-2018-00436
• Device Sequence Number: 16456283
• Product Code: MCW
• UDI-Device Identifier: 00643169792302
• UDI-Public: 00643169792302
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 03/02/2018

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: 09/21/2020
• Device Catalogue Number: H1-M
• Device Lot Number: A528290
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2018
• Initial Report FDA Received Date: 03/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR