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	No Consequences Or Impact To Patient (2199)
Date of Event	09/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation summary: the hawkone was inspected and noted the power switch on the cutter driver was in the off position.No damages or anomalies were observed to the cutter driver.The hawkone showed no damages to the torque shaft or slide cover assembly.The cutter blank was exposed in the cutter window with the thumb switch retracted.Biological debris was noted distal the cutter head.The distal assembly was inspected under microscope.Bending to the laser drilled coils was observed approximately 0.8 cm from the cutter window.The cutter driver was powered on and was successfully able to retract the cutter back into the cutter window as intended.A dried blue substance was noted on the cutter.The blue substance would flake off from the cutter.The blue substance was likely contrast, no components from the hawkone device have this color.Functional testing: with the cutter driver activated the thumb-switch was advanced.The cutter met resistance at approximately 0.6 cm distal the cutter window.
Event or Problem Description
The physician was attempting to use a hawk one directional atherectomy device to treat a 200 mm plaque lesion in the right sfa with little calcification.The artery had no tortuosity with a diameter of 5 mm and had 75% stenosis.No abnormalities were reported in relation to the patient¿s anatomy.The procedure utilized a 6 fr non-medtronic sheath and a 0.014" spider guidewire.The vessel was not pre-dilated but was post dilated.The ifu was followed throughout the procedure.It was reported that the device worked on the first advance and was cleaned, but during the second advancement the physician noticed the blade was not in its typical starting position radiographically.Upon inspection of the device, the blade would not retract and pack the plaque properly to the end of the nose cone, the device was not operating correctly.It was reported that the physician thinks there would be an increased chance of emboli due to the mechanical problem.Plaque was stuck in the proximal end of the nose cone, and the blade could not fully retract, le aving almost no room to extract and properly collect plaque within the device.The cutter driver could be returned to the housing and the thumb switch was operational.No irregular sounds were emitted from the device.Another hawkone device was used to complete the procedure.Patient blood flow has improved.No injury to the patient 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: 6939449
• Report Number: 2183870-2017-00439
• Device Sequence Number: 852376
• 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: 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
• Report Date (Section B): 09/11/2017

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: 05/09/2020
• Device Catalogue Number: H1-M
• Device Lot Number: A457838
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2017
• Initial Report FDA Received Date: 10/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Weight: 59