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

Catalog Number H1-M-INT

Device Problem Material Deformation (2976)

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

Event Date 04/17/2023

Event Type  malfunction  

Manufacturer Narrative

Product analysis the image shows the distal end of a hawkone device.The distal flush tool (dft) is positioned over the housing at the distal end of the device.The housing is detached from the rest of the device.The detachment appears to have occurred distal to the anchor pockets.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.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 physician was using a hawkone atherectomy device for the treatment of a 250mm calcified plaque lesion with 50-80% stenosis in the proximal region of the superficial femoral artery.The artery was 6mm in diameter and it was severely calcified and mildly tortuous.A 6fr non medtronic sheath was used.A 5mm spider was used for embolic protection.The lesion was not pre-dilated.The ifu was followed, it was reported the hawkone was inserted into proximal sfa lesion, and used twice.No issues were noted during cleaning after first use.After the second use, once removed from the patient, the distal flush tool was found unable to slide back to the proximal end of the hawkone and nosecone area was found to be damaged.Cutter was noted to be damaged.The catheter did not experience difficulty locking into the cutter driver.The first 2 times it was possible to turn off the thumbswitch and the trigger could be fully pulled up to turn off the thumbswitch.For the third time, it could not be fully pulled up to turn off the thumbswitch.The cutter driver did not stop functioning while device in use in patient.The device was safely removed from the patient.The hawkone was not used after this, dcb was used to post dilate.No patient injury reported.Images of the device were received and reviewed and confirmed the device was damaged.

Manufacturer Narrative

Product analysis the device was returned with the distal flush tool (dft) positioned over the housing/tip.A visual inspection showed that the housing/tip detached distal to the anchor pockets product analysis the customer returned one image.The image shows the distal end of a hawkone device.The distal flush tool (dft) is positioned over the housing at the distal end of the device.The housing is detached from the rest of the device.The detachment appears to have occurred distal to the anchor pockets.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: 17085006
• MDR Text Key: 316756728
• Report Number: 9612164-2023-02446
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: HK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 07/31/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 12/02/2023
• Device Catalogue Number: H1-M-INT
• Device Lot Number: 0010477102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/25/2023
• Initial Date FDA Received: 06/08/2023
• Supplement Dates Manufacturer Received: 07/27/2023
• Supplement Dates FDA Received: 07/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0450-2022
• Patient Sequence Number: 1
• Patient Sex: Male