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

Model Number	H1-LX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	05/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Physician used a hawkone directional atherectomy device along with a non medtronic 7fr sheath, a 0.014 guide wire and spider fx 7mm embolic protection to treat severely calcified fibrous plaque lesion in the right mid sfa with 95% stenosis.The vessel diameter was 6mm and 40mm respectively.The vessel was little tortuous.The vessel was not pre dilated but post dilated.Ifu was followed.It was reported that upon removing the hawkone device, perforation and fistula formation was noted.Physician then chose to place a 7x100 non medtronic stent to cover injured area and post dialated with a 6x40 pta balloon.The post procedure images showed patient vessel and doppler pulses.
Additional Manufacturer Narrative
Product analysis: the hawkone connected to a cutter driver was returned to medtronic investigation lab.No other ancillary devices were included.The hawkone was inspected and found the distal flush tool was placed over the distal assembly.The dft was removed and noted the cutter was advanced approximately 2.2cm.Traces of dried biologics were noted within the housing of the hawkone.No damages or anomalies were observed.Image review: two cine images from the procedure.The first image evaluated appears to show the vessel prior to treatment.A guide wire is observed with contrast administered to the vessel.No indication of a hawkone inserted was noted.The second image likely shows the same vessel after treatment.There is no visual of a hawkone device inserted the vessel; however, there is an area of the vessel where it appears contrast is leaking through the vessel.It is possible this is the area of the reported perforation.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: there was no resistance felt or seen with the passes.Four total passes were made in four quadrants.There was no resistance felt upon removal of the device.The device was removed with the blade inside the cutter housing.No device damage was noticed.There was no further patient injury reported and the patient is stable.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.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): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 10101270
• Report Number: 9612164-2020-02033
• Device Sequence Number: 19711507
• Product Code: MCW
• UDI-Device Identifier: 00643169968509
• UDI-Public: 00643169968509
• 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,Followup
• Report Date (Section B): 07/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/25/2022
• Device Model Number: H1-LX
• Device Catalogue Number: H1-LX
• Device Lot Number: 0009941476
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2020
• Initial Date Received by Manufacturer: 05/27/2020
• Supplement Date Received by Manufacturer: 06/03/2020; 07/16/2020
• Initial Report FDA Received Date: 05/29/2020
• Supplement Report FDA Received Date: 06/05/2020; 07/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention