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

Catalog Number	H1-LX
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/28/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Physician used a hawkone directional atherectomy device with a non-medtronic 7fr sheath and 7.0 spider fx embolic protection device for the treatment of a 250mm slightly calcified plaque lesion in the left sfa of diameter 6mm.Lesion exhibited cto (chronic total occlusion-100%).Ifu followed and device prepped without issue.Vessel was not pre-dilated.It was reported that during the procedure, the device would not pack and thumb switch would not advance.This occurred after the 3rd pass of the 4th run.The device had been cleaned successfully on the 3 previous runs.The thumb switch could be turned off but it was difficult.The cutter could not be packed.No deformity in the cutter was observed.Another device was opened to complete the procedure.The vessel was post-dilated.No patient injury reported.
Additional Manufacturer Narrative
Device evaluation summary: the hawkone device was returned with the cutter attached to it.The device was inspected and observed the torque shaft was bent approximately 90 degrees beneath the strain relief.The distal assembly laser drilled tip body was crushed/flattened approximately 4.5cm distal the cutter window.The hawkone was received with the cutter approximately 1cm distal the cutter window.The cutter driver was activated and the thumb-switch retracted.The cutter was able to retract back into the cutter window as expected.The thumb-switch was advanced and the cutter was able to move forward approximately 2.5cm 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 (IRVINE); 9775 toledo way; irvine CA 92618
• MDR Report Key: 6822341
• Report Number: 2183870-2017-00360
• Device Sequence Number: 18846993
• Product Code: MCW
• UDI-Device Identifier: 00821684057933
• UDI-Public: 00821684057933
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 08/28/2017

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: 09/10/2018
• Device Catalogue Number: H1-LX
• Device Lot Number: A158813
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2017
• Initial Date Received by Manufacturer: 07/28/2017
• Supplement Date Received by Manufacturer: 08/28/2017
• Initial Report FDA Received Date: 08/25/2017
• Supplement Report FDA Received Date: 09/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR