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

Model Number	H1-M
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/09/2016
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 was attempting to treat a moderately calcified lesion with little tortuosity in the sfa of a patient using hawkone atherectomy device, it was reported that the thumb switch jammed.Device was cleaned after first insertion.Second insertion thumb switch still did not feel normal to tech.After one pass the physician noticed the cutter blade on angio was outside of nose cone and would not go back into cutter window.Physician did not finish cutting the lesion and removed the device through the sheath.Physician used dcb on remaining stenosis.No patient injury reported for this event.
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 (IRVINE); 9775 toledo way; irvine CA 92618
• MDR Report Key: 6147530
• Report Number: 2183870-2016-00699
• Device Sequence Number: 13555009
• Product Code: MCW
• UDI-Device Identifier: 00643169728769
• UDI-Public: 00643169728769
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2016

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: 09/12/2017
• Device Model Number: H1-M
• Device Lot Number: A320279
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/09/2016
• Supplement Date Received by Manufacturer: 11/09/2016
• Initial Report FDA Received Date: 12/06/2016
• Supplement Report FDA Received Date: 09/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1