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

Catalog Number	H1-M
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: the hawkone was returned with a cutter driver attached.No other ancillary devices were included.Visual inspection: the hawkone was inspected and observed the torque shaft showed an approximate 90-degree bend beneath the strain relief.The thumb switch was advanced and the cutter was located approximately 2.2 cm distal the cutter window.Biological debris was observed within the cutter housing.No damage to the distal assembly was observed.Functional testing: the cutter driver was activated and pulled the thumb switch back.The cutter retracted and biological debris was noted behind the cutter.The thumb switch was advanced and the cutter advanced to approximately 1.4cm distal the cutter window until resistance was encountered.The distal flush tool was placed over the distal assembly and the housing was flushed with water.The thumb switch was retracted and advanced and the cutter advanced approximately 2.4cm.Under microscope biological debris was observed at the distal edge of the cutter.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician attempted to use a hawkone with a 6fr terumo sheath & 3mm spider to treat a severely calcified lesion with little tortuosity and 99% stenosis in the mid left popliteal artery as per the ifu.No patient abnormalities were reported.The vessel was pre and post dilated.It was reported that after performing 3 passes the thumb switch would not fully move to off position and therefore was unable to pack tissue.The hawkone was removed from the patient with the cutter blade inside the housing, once removed further attempts to turn the device to the off position were unsuccessful, no visible damage to the cutter reported.A new device was opened to finish the procedure with no issues noted.At the end of procedure, further attempts did get the thumb switch to finally go to full off position.No patient injury reported.

• Brand Name: HAWKONE 6FR
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): COVIDIEN; 9775 toledo way; irvine CA 92618
• MDR Report Key: 7662454
• Report Number: 9612164-2018-01627
• Device Sequence Number: 1979548
• Product Code: MCW
• UDI-Device Identifier: 00643169792302
• UDI-Public: 00643169792302
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 07/04/2018

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: 09/21/2020
• Device Catalogue Number: H1-M
• Device Lot Number: A528290
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2018
• Initial Report FDA Received Date: 07/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Patient Weight: 88