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

Catalog Number	H1-M
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/30/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician was attempting to use a hawkone directional atherectomy device to treat a 3 cm lesion in the sfa.The artery had a diameter of 5mm.The device was prepped as per the ifu with no issues identified.The guidewire was hydrated during preparation.The procedure used a 6fr non-medtronic sheath and a.014" non-medtronic guidewire.It was reported that no resistance was experienced when the hawkone was advanced over the bifurcation.It was reported that the guidewire became stuck on the catheter.The hawkone and the guidewire were removed in tandem.A new.014" non-medtronic guidewire was introduced and balloon angioplasty was performed successfully.No patient injury was reported.
Additional Manufacturer Narrative
Evaluation summary: the hawkone was returned with a green 0.014" guidewire loaded with the device and the hawkone was attached to a cutter driver.No other ancillary devices were included.The hawkone was inspected and the torque shaft was observed to be bent at an approximate 90 degree angle beneath the strain relief.The distal assembly was curved with the 0.014" guidewire loaded.No tears to the guidewire tubing were noted.The proximal end of the guidewire tubing showed the rim of the tubing stretched out, however not torn.The guidewire was pulled proximally.Resistance was encountered, after approximately 5 cm.It was discovered the segment of the guidewire loaded over the distal assembly was bent at two locations.At the angle of each bend, the guidewire showed the green outer layer of the wire worn away.The bends were approximately 2cm apart.After the bent portion of the guidewire was not loaded in the guidewire tubing of the hawkone, the guidewire could be pulled back and pushed forward with no resistance.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: 7073578
• Report Number: 2183870-2017-00532
• Device Sequence Number: 13732838
• 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: K141801
• 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): 01/17/2018

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: 07/31/2020
• Device Catalogue Number: H1-M
• Device Lot Number: A500806
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2017
• Initial Date Received by Manufacturer: 11/01/2017
• Supplement Date Received by Manufacturer: 12/19/2017
• Initial Report FDA Received Date: 11/30/2017
• Supplement Report FDA Received Date: 01/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1