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

Catalog Number H1-LX-INT

Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907); Material Deformation (2976)

Patient Problem Insufficient Information (4580)

Event Date 06/15/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Physician was using hawkone directional atherectomy along with a 7fr sheath, spider fx guidewire and 7mm embolic protection during procedure to treat a severely calcified lesion in the right common femoral artery (cfa) with 90% stenosis.The vessel was none tortuous.The vessel diameter and lesion length were 7mm and 30mm respectively.The vessel was not pre or post dilated.Ifu was followed.During withdrawal, severe resistance was felt and the tip detached in vivo but did not separate at hinge pin.It was reported that wire prolapse was noted during device withdrawal, there were two loops formed.The device was stuck to the wire and the tip appeared to detach from the hawk during device withdrawal.The tip, wire and rest of the device all became stuck in the patient, could not be advanced or retracted.The up and over sheath was advanced to the opposite groin where a cut down was performed to remove the tip, spider and device.Upon inspection, the tip had not detached but the wire was tightly wound round the device so it would not move/ could not be retrieved in any other way. cut down of common femoral artery was done to retrieve all components (spider, hawk).No further patient injury reported.

Manufacturer Narrative

Additional information: the cutter was inside the housing when removed from patient.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.

Manufacturer Narrative

Product analysis a visual inspection showed that the tip/housing is not detached from the device, (photo 5) but as reported the torque shaft was cut in order to remove it from the body a portion of a spider fx wire is stuck in the detached section of the device and is wrapped around the tip/housing the guidewire lumen on the tip/housing is ripped, (photo 8) and the wire is confirmed as 0.014 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 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: 14798894
• MDR Text Key: 295028282
• Report Number: 9612164-2022-02395
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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,Followup,Followup
• Report Date: 10/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: H1-LX-INT
• Device Lot Number: 0010877383
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2021
• 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 Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male