MAUDE Adverse Event Report: COVIDIEN (IRVINE) HAWKONE 7F; CATHETER, PERIPHERAL, ATHERECTOMY

Catalog Number	H1-LX
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation summary: the hawkone unit was returned for analysis.Upon visual inspection, it was found that the cutter driver power was in the off position.The distal flush tool was placed over the distal assembly with the cutter retracted within the cutter window.Outside of the flush mouth was a clear film-like material.It was noted the torque shaft beneath the strain relief was bent approximately 45 degrees.The material was pulled from the flush mouth using a tweezers.The debris/material was approximately 5.5cm long, the width was approximately 0.1cm.The debris appear excess material which was skived/stripped.The clear film-like material was pulled from the distal assembly and soaked in water for approximately 24 hours.The debris/material showed no signs of dissolving.The consistency of the material was flexible was stiff; however remained flexible (plastic-like).Additional debris located within the flush mouth was noted and removed which showed the similar characteristics as the strip of material removed.Functional testing was performed and the distal flush tool was removed and the cutter was advanced until resistance was encountered, which was approximately 1.8cm distal the cutter window.
Event or Problem Description
Physician was using a hawkone directional atherectomy device for treatment of a calcified plaque lesion in the right superficial femoral artery.The device was inspected with no issues identified.The ifu was followed.There was no resistance encountered in advancing device.It was reported that during the fourth cleaning of the device, the device could not be flushed.The device was successfully used and cleaned up until this without issue.The device did not want to turn off at the thumbswitch, so the physician turn off battery and manually hold thumb switch in off position to remove.There was no deformation noted to the cutter.Another hawkone device was used to complete the procedure.No patient injury reported.

• Brand Name: HAWKONE 7F
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• MDR Report Key: 6769184
• Report Number: 2183870-2017-00335
• Device Sequence Number: 1412638
• Product Code: MCW
• UDI-Device Identifier: 00821684057933
• UDI-Public: 00821684057933
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Report Date (Section B): 07/10/2017

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: 12/08/2018
• Device Catalogue Number: H1-LX
• Device Lot Number: A198731
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2017
• Initial Report FDA Received Date: 08/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1