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	Embolism (1829)
Date of Event	12/07/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Physician attempted to treat patient at the left mid/distal tibial artery and tibial/popliteal trunk using a hawkone directional atherectomy.Target lesion type was "plaque" and had little tortuosity, little calcification and 100% stenosis (cto).A 6f sheath and.014¿/3 mm spider embolic protection device were also used.Vessel was not pre-dilated.Ifu was followed.It is reported that device was operating normal at first.When nosecone was 3/4 full, the nosecone began to pack more distally.The nosecone then tore and plaque embolized downstream.Procedure was completed using ipa dcb's, stents and coronary des in tibial bifurcation.No further patient complications reported.
Additional Manufacturer Narrative
Evaluation summary: the hawkone device was returned for evaluation.The device was inserted in the cutter driver and a 3 ml bd syringe was connected to the distal flush tool.It was discovered there was a hole to the tecothane layer of the distal assembly approximately 2 cm distal the cutter window.The hole was on the same plane as the cutter window, opposite of the guidewire tubing.The hole shows the tecothane material protruding out and runs parallel with the coils.Red biological matter was observed at the location of the hole.
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: 6218308
• Report Number: 2183870-2017-00005
• Device Sequence Number: 10878822
• Product Code: MCW
• UDI-Device Identifier: 00643169728769
• UDI-Public: 00643169728769
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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,consum
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/13/2017
• Device Catalogue Number: H1-M
• Device Lot Number: A346308
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/07/2016
• Supplement Date Received by Manufacturer: Not provided; 01/19/2017
• Initial Report FDA Received Date: 01/03/2017
• Supplement Report FDA Received Date: 02/16/2017; 09/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention