MAUDE Adverse Event Report: MEDTRONIC IRELAND HAWKONE 7F; CATHETER, PERIPHERAL, ATHERECTOMY

Model Number	H1-LS
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	01/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Product analysis: hawkone with cutter driver was returned to medtronic investigation lab for evaluation.The device was connected to the cutter driver and inspected.The cutter was advanced within the housing 2.8cm distal to the cutter window.No structural damage noted to the metal housing.The guide wire tubing was disengaged distally approximately 1 cm proximal end of the guide wire tubing.No hole noted to the housing where tissue would escape.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information update: a spider embolic protection was used.Three passes were made initial prior to the issue.No additional debris passed beyond the spider.All components were still intact.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Physician intended to use a hawkone device during treatment of a calcified cto (chronic total occlusion-100%) in the patient¿s distal superficial femoral artery (sfa) of diameter 5-6mm.Slight vessel tortuosity and severe calcification are reported.Pre-dilation was performed using a non-medtronic 3mm balloon followed by a 4mm balloon.Several passes were made with the hawkone.It is reported the guidewire lumen on the top of the nosecone began to separate and debris was noted to have escaped.Once the separation was noted, the device was not used in the patient.The procedure is reported to have gone well, and no injury reported.

• Brand Name: HAWKONE 7F
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 9652366
• Report Number: 9612164-2020-00499
• Device Sequence Number: 16858976
• Product Code: MCW
• UDI-Device Identifier: 00643169968486
• UDI-Public: 00643169968486
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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,Followup,Followup
• Report Date (Section B): 03/24/2020

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: 04/18/2022
• Device Model Number: H1-LS
• Device Catalogue Number: H1-LS
• Device Lot Number: 0009704514
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2020
• Initial Date Received by Manufacturer: 01/29/2020
• Supplement Date Received by Manufacturer: 01/31/2020; 02/05/2020; 03/20/2020
• Initial Report FDA Received Date: 01/31/2020
• Supplement Report FDA Received Date: 02/04/2020; 02/06/2020; 03/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1