MAUDE Adverse Event Report: MEDTRONIC IRELAND HAWKONE 6FR; CATHETER, PERIPHERAL, ATHERECTOMY

Model Number H1-M

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/06/2021

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Physician intended to use a hawkone m atherectomy device with a 6fr non-medtronic sheath and a 5mm spider fx embolic protection device during treatment of a 150mm plaque lesion in the patient¿s right proximal mid distal superficial femoral artery.No vessel tortuosity and little vessel calcification are reported.Lesion exhibited 90% stenosis.Artery diameter reported as 5mm.The ifu (instruction for use) was followed during preparation, procedure, post-procedure.The vessel was not pre-dilated.The vessel was post-dilated.It is reported that during the procedure, the device would not successfully pack after the first pass.It was possible to turn off the thumbswitch.Cutter driver/thumbswitch stopped functioning while in use in patient.Cutter was inside the housing when the thumbswitch stopped functioning.It was removed, cleaned, and still would not successfully pack.Cutter was inside the housing unit during removal from patient but not back completely.Device was safely removed from patient.No deformation to cutter.A second hawkone m device was opened and used to successfully complete the procedure.No patient injury reported.

Manufacturer Narrative

Device evaluation the device was returned with the thumbswitch positioned halfway, and a sharp bend on the strain relief the device was returned with the cutter positioned approximately 8mm in housing, there is a bulge on the housing, and it appears that there is biologics present at 14mm during functional testing when the thumbswitch was retracted and the cutter returned to the cutter window when the thumbswitch was advanced the torque shaft broke under the strain relief no further functional testing could be carried out due to the condition of the 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.

• Brand Name: HAWKONE 6FR
• Type of Device: 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: 12984365
• MDR Text Key: 285490618
• Report Number: 9612164-2021-04815
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 00643169968332
• UDI-Public: 00643169968332
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2024
• Device Model Number: H1-M
• Device Catalogue Number: H1-M
• Device Lot Number: 0010643493
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/15/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female