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

Catalog Number H1-M

Device Problems Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)

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

Event Date 09/06/2023

Event Type  malfunction  

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 have not 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 intended to use a hawkone m atherectomy device during treatment of a calcified lesion in the patient¿s mid superficial femoral artery (sfa).Little vessel tortuosity and severe vessel calcification are reported.The vessel was not pre-dilated.The vessel was post-dilated.The ifu (instruction for use) was followed during preparation, procedure, post-procedure.It is reported the thumb switch seemed to not want to engage, and/or the plunger broke off and wasn't allowing on/off switch to function properly, it cannot be confirmed if plunger fully detached.The position of the cutter in relation to the nosecone during device removal from the patient was unknown.The device was safely removed from patient and no vessel damage noted after removal.There was no requirement to snare or cut down, the hawk simply quit working, so it was removed.A hawkone lx device was used to complete procedure.No patient injury reported.

Manufacturer Narrative

Product analysis: the device was returned with the thumbswitch beside the ¿on¿ position and with the distal flush tool (dft) positioned over the housing.When the dft was retracted a visual inspection of the housing found that the distal end of the cutter window was damaged, and that when the cutter was advanced it was catching on the cutter window due to the damage.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: 17869853
• MDR Text Key: 324910602
• Report Number: 9612164-2023-04481
• 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: 11/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: H1-M
• Device Lot Number: 0011730024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/09/2023
• Date Device Manufactured: 04/12/2023
• 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: 58 YR
• Patient Sex: Female