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

Catalog Number	H1-M
Medical Device Problem Code	Split (2537)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Image analysis summary: the hawkone device was not received for evaluation.No ancillary devices from the procedure were received for evaluation.Three photographic images were received with the initial reported event.The first image is of the hawkone directional atherectomy system distal assembly.Approximately at half the distance between cutter window and the distal tip a bulge in the tecothane between two struts is present.The bulge of material appears to run parallel to the struts.Due to the quality and clarity of the image it is not possible to determine if a breach in the tecothane is present, presence of mec holes along the length of the distal assembly, or if a strut is damaged.Due to the angle of the photograph the guidewire lumen is not visible: it is not possible to determine if evidence of guidewire prolapse is present.The cutter head is not present in the cutter window.The location of the cutter head within its packing stroke within the distal assembly cannot be determined in the photograph.The second image is of a cine image and appears to be a before treatment cine.The third image is a cine image and appears to be an after-treatment cine.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 was using a hawkone m device with a 6f sheath and 5mm.014 embolic protection device for treatment of a 200mm non-tortuous moderately calcified lesion which exhibited 100% lesion stenosis in the superficial femoral artery (sfa) of diameter 6mm.The ifu was followed and the vessel was not pre-dilated.Multiple passes were made down the sfa without issue.The device would then not flush.The nose cone was removed from the tool and a break was observed in the nose cone.The nose cone had plaque breaking through.The procedure was successfully completed by using a new device.Vessel was post-dilated.No patient injury reported.
Additional Manufacturer Narrative
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; 9775 toledo way; irvine CA 92618
• MDR Report Key: 6628995
• Report Number: 2183870-2017-00246
• Device Sequence Number: 13766765
• Product Code: MCW
• UDI-Device Identifier: 00643169728769
• UDI-Public: 00643169728769
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 05/11/2017

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: 11/30/2019
• Device Catalogue Number: H1-M
• Device Lot Number: A382561
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/11/2017
• Supplement Date Received by Manufacturer: 05/11/2017
• Initial Report FDA Received Date: 06/09/2017
• Supplement Report FDA Received Date: 09/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Weight: 95