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

Catalog Number	H1-LS
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Intimal Dissection (1333)
Date of Event	11/29/2017
Type of Reportable Event	Serious Injury
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 directional atherectomy device to treat a 150mm plaque lesion with little calcification in the proximal sfa.The vessel had a diameter of 6.5mm and had little tortuosity.The lesion had 80% stenosis.The procedure used a 7 fr non-medtronic sheath and a non-medtronic 300mm guidewire.The vessel was pre- but not post dilated.The device was prepped as per the ifu with no issues identified.It was reported that the nosecone of the device was bulging with plaque.The nosecone was intact aside from the bulge.The device had not been over packed.The same issue occurred with a second hawkone device.The cutter driver/thumbswitch did not stop functioning while in use in patient.The atherectomy procedure caused a dissection in the vessel.A 6mm protege stent was used to complete the procedure due to the dissection.No patient injury was reported.
Additional Manufacturer Narrative
Product analysis: the hawkone device was returned attached to a cutter driver.No ancillary devices were included.Visual inspection: the hawkone was inspected and it was observed that the tecothane was bulged out approximately 2cm distal the cutter window.The damage was on the top plane of the distal assembly (opposite guidewire tubing).Under microscope the location of the expanded tecothane showed biological material beneath the expanded tecothane.The tecothane was expanded/stretched and bending of the laser drilled coils were noted.No observation of a tear or hole was noted.Functional testing: the thumb-switch was retracted and advanced with encountered resistance.The cutter could not advance past 1.5cm from the cutter window.If information is provided in the future, a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; 9775 toledo way; irvine CA 92618
• MDR Report Key: 7138248
• Report Number: 2183870-2017-00609
• Device Sequence Number: 13720569
• Product Code: MCW
• UDI-Device Identifier: 00821684057926
• UDI-Public: 00821684057926
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 03/06/2018

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: 09/21/2019
• Device Catalogue Number: H1-LS
• Device Lot Number: A347382
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2018
• Initial Date Received by Manufacturer: 11/29/2017
• Supplement Date Received by Manufacturer: 02/05/2018
• Initial Report FDA Received Date: 12/21/2017
• Supplement Report FDA Received Date: 03/06/2018
• 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