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

Catalog Number H1-M-INT

Device Problems Entrapment of Device (1212); Detachment of Device or Device Component (2907); Difficult to Advance (2920)

Patient Problem Insufficient Information (4580)

Event Date 06/07/2022

Event Type  Injury  

Manufacturer Narrative

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

Physician was attempting to use a hawkone directional atherectomy along with a non-medtronic 6fr sheath, spider fx 0.014" guidewire and 7mm embolic protection during procedure to treat a severely calcified lesion in the left mid common femoral artery (cfa) with 90% stenosis.The vessel was severely tortuous.The vessel diameter and lesion length were 506mm and 120mm respectively.The vessel was pre dilated but not post dilated.Ifu was followed.It was reported that during withdrawal, severe resistance was felt and the tip detached.The tip separated at the hinge pin.The guidewire prolapse neither caused tip damage or embolization during procedure.When the device was removed to clean, it was then noticed the tip from the cutter forward was missing.Under fluoroscopy, the detached piece was found still attached to the spider fx wire.The vascular trainee was asked if he had felt resistance and he said yes quite a bit but thought it was just the device coming in to sheath.Especially with the toto's aortic bifurcation so he just yanked it and it came out, not realizing what had happened.Guidewire advancement/ lock-up/ prolapse/ lumen torn/ ripped occurred.The device was advanced over bifurcation.The guidewire was hydrated at preparation.The guidewire lumen did not tear from the distal tip.Procedure was completed with a cutdown on the puncture side which also included an endarterectomy.The patient was going to have this at a later date so the clinical and patient outcome was better than expected pre procedure.There was complications associated with this event.Required cut down to remove, however patient was set to come back for an endarterectomy on the cut down side in the near future so this was performed at the same time which in fact improved the patient outcome and stopped the need for a second procedure.No further patient injury.

Manufacturer Narrative

Product analysis a visual inspection showed that the tip detached adjacent to the anchor pockets a portion of a spider fx device is stuck in the detached section of the tip and the guidewire is ripped image analysis the customer returned six images and one video.The video appears to show an attempt to retract the tip into the sheath.Image 1 appears to show the patient¿s vasculature.There appears to be contrast in the artery and a guidewire.Images 2 and 3 are very unclear and are difficult to analyse.Image 4 appears to show a guidewire passing through the patient¿s vasculature.Images 5 and 6 appear to show the patient¿s vasculature.There appears to be contrast in the artery and a guidewire.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: 14785692
• MDR Text Key: 294564086
• Report Number: 9612164-2022-02379
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K161361
• 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: 12/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/06/2023
• Device Catalogue Number: H1-M-INT
• Device Lot Number: 0010300070
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/06/2020
• 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 Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Sex: Female