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

Catalog Number H1-LS-INT

Device Problems Deformation Due to Compressive Stress (2889); Material Deformation (2976)

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

Event Date 12/25/2023

Event Type  malfunction  

Manufacturer Narrative

Product analysis the device was returned with the thumbswitch stuck on the ¿on¿ position and it could not be moved.A visual inspection found that there was no cutter in the device indicating that it detached.There was no kink visible on 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.

Event Description

A hawkone ls was used for debulking the severe stenosis, which was located in the superficial femoral artery.The lesion was calcified with 90% stenosis.There was mild tortuosity and severe calcification.The ifu was followed.A 5mm embolic protection device was used.The lesion was pre and post dilated.  it was reported after the physician removed hawkone for second time flushing, it was noted that the shape/elasticity of the tip looked different, there was a kink located at the proximal tip, near the location of blade, the physician used a new hawkone.Device for debulking.The physician was debulking the target lesion for 3-4 times and post dilated the lesion with evercross 6.0mm balloon and finally successfully completed this procedure, most of stenosis was removed and the physician is satisfied with procedure result.No patient symptoms or complications associated with this event.The damaged tip remained attached to the hawkone device.When the device was returned to the manufacturing facility it was noted that the the cutter detached.

• Brand Name: HAWKONE 7FR
• 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: 18873285
• MDR Text Key: 337294070
• Report Number: 9612164-2024-01191
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K141801
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: H1-LS-INT
• Device Lot Number: 0010957365
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/25/2021
• 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 Age: 84 YR
• Patient Sex: Female