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

Catalog Number	H1-LS
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician was attempting to use a hawkone atherectomy device to treat a 80 cm fibrous chronic total occlusion with little calcification in the mid left sfa.The diameter of the artery was 6 mm.The procedure used a spider 6mm guidewire and a 7 fr competitor sheath.The device was prepped as per the ifu with no issues identified.Plaque ruptured through nosecone when packed.No intervention was required.No patient injury was reported.
Additional Manufacturer Narrative
Device evaluation summary: the returned hawkone device was inspected - dried blood was observed within and outside of the distal assembly.A hole to the tecothane was observed approximately 4cm distal the cutter window.The hole was on the opposite plane of the guidewire tubing.Under microscope the hole showed the tecothane material pushing outwards and the hole ran parallel to the laser drilled coils.If information is provided in the future, a supplemental report will be issued.

• Brand Name: HAWKONE 7F
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): COVIDIEN IRVINE; 9775 toledo way; irvine CA 92618
• MDR Report Key: 7056785
• Report Number: 2183870-2017-00527
• Device Sequence Number: 126339
• Product Code: MCW
• UDI-Device Identifier: 00821684057926
• UDI-Public: 00821684057926
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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,Followup
• Report Date (Section B): 12/18/2017

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: 10/10/2019
• Device Catalogue Number: H1-LS
• Device Lot Number: A357339
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2017
• Initial Date Received by Manufacturer: 10/26/2017
• Supplement Date Received by Manufacturer: 11/28/2017
• Initial Report FDA Received Date: 11/23/2017
• Supplement Report FDA Received Date: 12/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR