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 05/18/2022

Event Type  malfunction  

Event Description

Physician was attempting to use a hawkone directional atherectomy along with 6fr 55cm sheath and a 6fr embolic protection during procedure to treat a moderately calcified fibrous lesion (moderately multifocal lesions) in the left mid to distal superficial femoral artery (sfa) to popliteal artery (pop).The vessel was none tortuous.The vessel was not pre dilated but post dilated.Ifu was followed.Physician unable to flush tissue.It was reported that after multiple passes, device was reinserted and thumbswitch did not fully engage but was able to be turned on.The position of the cutter is unknown when device was being removed from patient or being returned into housing.The device was removed and a new hawkone device was used to complete the procedure.There was no complications associated with this event.There was no patient injury reported.

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.

Manufacturer Narrative

Product analysis: the device was received with no cutter driver and the thumbswitch positioned in the ¿off¿ position, the device was received with the distal flush tool (dft) positioned over the housing the cutter was positioned approximately 29mm from the cutter window a cutter driver from lab was attached, thumbswitch was retracted and cutter returned to cutter window.There was blue material, most likely from a surgical wipe, wrapped around cutter blue material was removed, and a visual inspection found damage to distal edge of cutter window.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 company may not have been able to fully investigate or verify prior to date report was required by fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to company as of submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that device, medtronic, or its employee caused or contributed to event described in report.In particular, this report does not constitute an admission by anyone that product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in fda 3500a form and are fixed items for selection created by fda to categorize type of event solely for purpose of regulatory reporting.Medtronic objects to use of these words and others like them because of lack of definition and connotations implied by these terms.This statement should be included with any information or report disclosed to public under freedom of information act.Any required fields that are unpopulated are blank because information is currently unknown or unavailable.A good faith effort will be made to obtain applicable information relevant to report.If information is provided in 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: 14785380
• MDR Text Key: 302338631
• Report Number: 9612164-2022-02376
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/26/2022

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 Model Number: H1-M
• Device Catalogue Number: H1-M
• Device Lot Number: 0010982459
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/01/2022
• Initial Date FDA Received: 06/23/2022
• Supplement Dates Manufacturer Received: 08/25/2022
• Supplement Dates FDA Received: 08/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/13/2021
• 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: 67 YR
• Patient Sex: Male