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

Catalog Number	H1-S
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/09/2017
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 directional atherectomy device to treat a 60 mm fibrous lesion with little calcification in the distal sfa.The artery was non-tortuous, 5 mm in diameter and had 70% stenosis.The procedure used a 6fr non-medtronic 45 cm sheath and 5 mm embolic protection.The lesion was not pre-dilated but was post-dilated.The hawkone was prepped as per the ifu with no issues identified.The guidewire was hydrated at preparation.The hawkone was advanced over the bifurcation.It was reported that the physician experienced severe resistance while withdrawing the device, and the wire ripped through the wire lumen on nosecone when removing at sheath.The tip did not separate at the hinge point.The guidewire did not lock up on the catheter and the guidewire lumen was not torn on the distal tip.The physician did not notice the guidewire prolapse.A new hawkone device was used to complete the procedure.No patient injury was reported.
Additional Manufacturer Narrative
Device evaluation summary: the hawkone was returned with a cutter driver inserted.The hawkone was inspected- the torque shaft was bent at an approximate 90 degree angle beneath the strain relief.The structural integrity of the laser drilled coil segment of the hawkone was compromised.It was discovered the distal assembly was curved back around itself with biological debris within the inner diameter of the distal assembly.The guidewire tubing of the laser drilled coiled section showed a zipper tearing throughout the component.The proximal end of the guidewire tubing showed a piece of the tubing flared out and detached.The laser drilled coils where observed compressed against each other at the areas of the curve.Due to the damage observed, the distal assembly was more flexible than intended.It was verified the cutter assembly was attached to the distal end of the drive shaft.If information is provided in the future, a supplemental report will be issued.

• Brand Name: HAWKONE 6FR
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): COVIDIEN IRVINE; 9775 toledo way; irvine CA 92618
• MDR Report Key: 7008598
• Report Number: 2183870-2017-00481
• Device Sequence Number: 10873736
• Product Code: MCW
• UDI-Device Identifier: 00643169728783
• UDI-Public: 00643169728783
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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,Followup
• Report Date (Section B): 12/07/2017

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: 01/24/2020
• Device Catalogue Number: H1-S
• Device Lot Number: A404815
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2017
• Initial Date Received by Manufacturer: 10/09/2017
• Supplement Date Received by Manufacturer: 11/08/2017
• Initial Report FDA Received Date: 11/07/2017
• Supplement Report FDA Received Date: 12/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR