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

Model Number	H1-LX
Medical Device Problem Codes	Device Damaged by Another Device (2915); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation the device was returned loaded in a 7fr sheath there is a spider fx wire loaded through the guidewire lumen and with the proximal end of the housing is stretched.The proximal end of the guidewire lumen and tecothane is detached no functional testing could be carried out due to the condition of the returned device.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.
Event or Problem Description
Physician was attempting to use hawkone directional atherectomy along with a non-medtronic 7fr sheath and 7mm spider guidewire during procedure to treat a severely calcified, plaque lesion in the left proximal, mid and distal superficial femoral artery (sfa) with 90% stenosis.The vessel was moderately tortuous.The vessel diameter and lesion length are 6mm and 400mm respectively.The device was inspected with no issues noted.The device was prepped per ifu with no issues identified.It was reported that the wire prolapsed upon removal of device.The physician was careful when rotating the device, our thoughts were maybe the spider wire got caught on some calcium near the sheath and looped around when removing.The guidewire lumen was torn/ripped.The damaged component remained attached.The prolapse did not result in intervention for removal of devices.Patient was not harmed, everything was removed except for a v18 wire to keep access.After removal another 7f sheath was placed and we finished the case with dcb and chocolate.There was no patient injury.When the device was returned to the facility for evaluation it was noted that the device was damaged.

• Brand Name: HAWKONE 7F
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 15787610
• Report Number: 9612164-2022-04215
• Device Sequence Number: 17531025
• Product Code: MCW
• UDI-Device Identifier: 00643169968509
• UDI-Public: 00643169968509
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K141801
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/14/2022

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: 08/18/2024
• Device Model Number: H1-LX
• Device Catalogue Number: H1-LX
• Device Lot Number: 0010810759
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2022
• Initial Report FDA Received Date: 11/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Male