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

Catalog Number	H1-M
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/31/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation summary: the hawkone device was returned for analysis.The hawkone was inserted a cutter driver.A 7 f non-medtronic sheath was also included.The sheath showed dried blood within the valve.The sheath showed a ductile fracture approximately 1cm distal the manifold.The hawkone showed a ductile fracture at approximately 1cm distal the cutter window.The cutter assembly connected to the drive shaft was protruding outside the laser drilled coil.Blood was noted within the cutter window.The guidewire tubing showed a zipper tear.The distal portion of the distal assembly which fractured away from the catheter was not returned and unaccounted for at this time.
Event or Problem Description
Physician intended to use a hawkone directional atherectomy device with a 7 french non-medtronic sheath and 5mm spider fx embolic protection filter wire for the treatment of a moderately tortuous, severely calcified lesion in the mid popliteal artery.Lesion exhibited cto (chronic total occlusion-100%).Ifu was followed.It was reported that severe resistance was felt during withdrawal of the device and that the tip separated at the hinge pin.It was possible to turn off the thumbswitch.It was reported that the nosecone was stuck in the sheath.Force was applied and the nosecone broke into three pieces.All pieces were recovered in the sheath.The cutter was inside the housing for the safe removal of the device.Deformation was noted to the cutter but no pieces were noted to be missing.The procedure was completed as lesion was dilated with poba, and then in.Pact admiral drug coated balloon.No patient injury 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: 6829445
• Report Number: 2183870-2017-00362
• Device Sequence Number: 13463053
• Product Code: MCW
• UDI-Device Identifier: 00643169728769
• UDI-Public: 00643169728769
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 07/31/2017

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: 03/14/2020
• Device Catalogue Number: H1-M
• Device Lot Number: A429235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2017
• Initial Report FDA Received Date: 08/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1