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

Model Number H1-LS

Device Problems Detachment of Device or Device Component (2907); Device Damaged by Another Device (2915)

Patient Problem Vascular Dissection (3160)

Event Date 12/10/2021

Event Type  Injury  

Event Description

Physician was attempting to use a hawkone atherectomy device to treat a little tortuous, little calcified, plaque lesion within the mid superficial femoral artery.Device prepped per ifu with no issues identified.It was reported that device was caught on a stent strut and was pinched.Device wouldn't come free so they called rep who talked them through getting the device free from the stent.Nosecone separated from catheter.No intervention was required for tip removal.It was trapped by the spider and removed with the sheath.The stent was damaged.Pieces of the stent were inside the nose cone.The vessel had a small dissection.The procedure was completed by accessing ipsilateral and placing another stent.No other complications were reported.There was no damage to the spiderfx device and the damaged stent was not a medtronic stent.No patient injury reported.

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

Physician was attempting to use a hawkone atherectomy device to treat a little tortuous, little calcified, plaque lesion within the mid superficial femoral artery.Device prepped per ifu with no issues identified.It was reported that device was caught on a stent strut and was pinched.Device wouldn't come free so they called rep who talked them through getting the device free from the stent.Nosecone separated from catheter.No intervention was required for tip removal.It was trapped by the spider and removed with the sheath.The stent was damaged.Pieces of the stent were inside the nose cone.The vessel had a small dissection.The procedure was completed by accessing ipsilateral and placing another stent.No other complications were reported.There was no damage to the spiderfx device and the damaged stent was not a medtronic stent.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.

• Brand Name: HAWKONE 7F
• 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: 13167189
• MDR Text Key: 286114623
• Report Number: 9612164-2022-00032
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 00643169968486
• UDI-Public: 00643169968486
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141801
• 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: 10/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/25/2024
• Device Model Number: H1-LS
• Device Catalogue Number: H1-LS
• Device Lot Number: 0010619806
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/03/2022
• Date Device Manufactured: 03/26/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male