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

Catalog Number	H1-M
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	10/10/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluation summary: the hawkone was inserted a cutter driver and 0.014" guidewire was loaded the distal assembly.Visual inspection: the hawkone was returned in two pieces.The first piece included the fractured distal end of the distal assembly.The distal assembly was loaded on the 0.014" guidewire and the total length of the guidewire was 300cm.The guidewire was bent at approximately 1 and 4 cm from the distal tip.The distal assembly was loaded on the guidewire approximately 94cm from the distal end.The total length of the distal assembly loaded on the guidewire was approximately 6cm.The distal assembly was inspected under a microscope.Dried blood was noted at the distal tip and within the laser drilled coils.The fracture face was inspected and observed a radial fracture at the bottom proximal end of the cutter window.The second piece of the hawkone was inspected.The cutter driver power switch was in the on position.The thumb-switch was advanced and the distal end of the drive shaft with the cutter assembly attached was observed sticking out at the end.The fracture to the distal assembly was inspected under a microscope.The fracture face was radial and exposed the bottom of the ramp.No damage to the ramp assembly was noted.The hinges pins were intact and not affected.The location of the fracture on the hawkone device was at the proximal portion of the cutter window.No damage to the top of the proximal end of the cutter window was observed; however, the fracture took place at the base/bottom of the cutter window.
Event or Problem Description
The physician was attempting to use a hawkone directional atherectomy device to treat a calcified 5 cm lesion in the mid sfa.The artery was described as having little tortuosity and was 5mm.No abnormalities were reported in relation to the patient¿s anatomy.The procedure used a 0.014" non-medtronic guidewire and a 6 fr non-medtronic sheath.The device was prepped as per the ifu.Neither pre- nor post-dilation of the vessel was performed.The physician did not experience any resistance during advancement.It was reported that the tip of the device detached proximal to the cutter.The tip was snared using a gooseneck snare and removed the patient¿s vessel.No patient injury was reported.

• Brand Name: HAWKONE 6FR
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): COVIDIEN IRVINE; 9775 toledo way; irvine CA 92618
• MDR Report Key: 7012226
• Report Number: 2183870-2017-00484
• Device Sequence Number: 1394033
• Product Code: MCW
• UDI-Device Identifier: 00643169792302
• UDI-Public: 00643169792302
• 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
• Report Date (Section B): 11/08/2017

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: 07/24/2020
• Device Catalogue Number: H1-M
• Device Lot Number: A497240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2017
• Initial Report FDA Received Date: 11/08/2017
• 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