MAUDE Adverse Event Report: METRONIC COVIDIEN HAWKONE 7F; CATHETER, PERIPHERAL, ATHERECTOMY

Catalog Number	H1-LS
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	02/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The hawkone was received for evaluation.No ancillary devices or cine images from the procedure were received.During visual inspection it was noted that the distal cutter assembly was separated from the cutter torque shaft at the torque shaft adaptor.Witness marks in the torque were present.Four weld witness marks on the torque shaft adaptor were present.The four pin crimps were present.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician intended to use a hawkone device during treatment of a severely calcified lesion in the mid superficial femoral artery.The vessel was described as being slightly tortuous.The device was prepped as per ifu without issue.It is reported the nosecone separated from the driveshaft.It was reported that it was possible to turn of the thumbswitch.The cutter driver thumbswitch did not stop functioning while in use in the patient.The device was safely removed from the patient.No deformation noted in the cutter.This issue was identified on the second insertion of the device.No patient injury reported.The device was replaced with another to finish the procedure.

• Brand Name: HAWKONE 7F
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): METRONIC COVIDIEN; 9775 toledo way; irvine CA 92618
• MDR Report Key: 7365503
• Report Number: 2183870-2018-00179
• Device Sequence Number: 16683399
• Product Code: MCW
• UDI-Device Identifier: 00821684057926
• UDI-Public: 00821684057926
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 03/23/2018

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: 12/09/2019
• Device Catalogue Number: H1-LS
• Device Lot Number: A387483
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2018
• Initial Report FDA Received Date: 03/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1