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	06/13/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Physician was using a hawkone directional atherectomy device with a 6 fr sheath and 5 mm.014 spider wire.Device ifu was followed.It was reported that the physician had difficulty fully sliding the thumb switch to the "off" position.When attempting to slide the cleaning/flush tool to the end of the catheter there was resistance, which then led to the physician pulling harder and the device breaking (damage to the center of nose cone - separation).No component needed to be removed from the patient.A new 6 fr hawkone was opened to complete the procedure.No patient injury reported.
Additional Manufacturer Narrative
Evaluation summary the hawkone was returned connected to a cutter driver.The distal flush tool was separated from the hawkone with a portion of the distal assembly inserted.The distal tip remained inside the distal flush tool.The tip of the distal assembly was approximately 2cm proximal to the black duckbill valve of the hawkone device.The fracture face on both segments was ductile in nature.Consistent with experienced excessive tensile forces applied.A bent of approximately 45 degrees was noted beneath the strain relief.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: 6709746
• Report Number: 2183870-2017-00300
• Device Sequence Number: 2013750
• Product Code: MCW
• UDI-Device Identifier: 00643169792302
• UDI-Public: 00643169792302
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 08/22/2017

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: 04/03/2020
• Device Catalogue Number: H1-M
• Device Lot Number: A439346
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2017
• Initial Date Received by Manufacturer: 06/13/2017
• Supplement Date Received by Manufacturer: 08/22/2017
• Initial Report FDA Received Date: 07/12/2017
• Supplement Report FDA Received Date: 09/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1