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

Catalog Number	H1-M
Medical Device Problem Codes	Battery Problem (2885); Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis: the hawkone was returned connected to a cutter driver.No other ancillary devices were included.During visual inspection, it was noted that the hawkone was connected to a cutter driver with the power switch in the on position.Biological debris was observed within the distal assembly and the cutter was approximately 2cm distal of the cutter window.No structural damage to the hawkone or cutter driver was noted.During functional testing, the thumb-switch was retracted and the cutter was pulled back into the cutter window.The cutter driver did not activate.Biological debris was observed behind and in front of the cutter head.The thumb switch was advanced and the cutter was able to advance approximately 2.3 cm distal of the cutter window.The hawkone was removed from the cutter driver and connected to a cutter driver from the lab.The cutter driver was powered on and the thumb switch was retracted.The cutter driver motor activated as intended.The cutter driver was opened and the battery was replaced with a lab 9v battery.After replacing the battery, re-connecting the hawkone and retracting the thumb-switch, the cutter driver activated as intended.The battery was connected to a multimeter in the lab and indicated 8.95 v.A batter from a known operation cutter driver was measured at 9.60v.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician was using a hawkone device with a non-mdt 6fr sheath and non-mdt.014 guidewire for the treatment of a 60mm, 80% stenosed plaque lesion in the mid left superficial femoral artery (sfa).The vessel was described as being non-tortuous and the artery diameter was 6mm.The vessel was not pre-dilated.The ifu was not followed.This event occurred intrastent and the device passed through a previously deployed unknown stent.It is reported the motor of the hawkone device stopped running.The thumb switch could be turned off but the cutter was positioned outside of the housing.The device was safely removed from the patient with no deformation noted in the cutter and an angioplasty was performed.No patient injury was reported.

• Brand Name: HAWKONE 6FR
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): COVIDIEN; 9775 toledo way; irvine CA 92618
• MDR Report Key: 7333400
• Report Number: 9612164-2018-00499
• Device Sequence Number: 18893903
• 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: 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
• Report Date (Section B): 03/13/2018

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: 07/10/2020
• Device Catalogue Number: H1-M
• Device Lot Number: A489429
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2018
• Initial Report FDA Received Date: 03/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1