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

Catalog Number	H1-M
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/04/2017
Type of Reportable Event	Malfunction
Event or Problem Description
The physician intended to use a hawkone atherectomy device during procedure for treatment of the right mid superficial femoral artery.The plaque lesion exhibited little tortuosity and calcification with chronic total occlusion (100%).The artery diameter is reported as 6mm with a lesion length of 300mm.A 6f terumo sheath and 6mm spider 0.014 guidewire were used during procedure.The vessel was not pre-dilated.The ifu was followed.It is reported that the blade was unable to be advanced back into the nosecone and the device could not be packed.A new h1-m was opened and the procedure was completed with it.No injury to patient was reported.
Additional Manufacturer Narrative
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 (IRVINE); 9775 toledo way; irvine CA 92618
• MDR Report Key: 6539502
• Report Number: 2183870-2017-00193
• Device Sequence Number: 340133
• Product Code: MCW
• UDI-Device Identifier: 00643169728769
• UDI-Public: 00643169728769
• 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,Followup
• Report Date (Section B): 04/04/2017

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: 07/15/2017
• Device Catalogue Number: H1-M
• Device Lot Number: A298158
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/04/2017
• Supplement Date Received by Manufacturer: 04/04/2017
• Initial Report FDA Received Date: 05/02/2017
• Supplement Report FDA Received Date: 09/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1