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

Catalog Number H1-M

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

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

Event Date 03/07/2024

Event Type  Injury  

Manufacturer Narrative

Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Physician attempted to use a hawkone m atherectomy device with a 65cm 6fr non-medtronic (terumo destination) sheath and a 4mm spider fx embolic protection device/guidewire during procedure to treat a calcified fibrous plaque lesion in the patients left proximal mid distal superficial femoral artery (sfa) & popliteal artery.Lesion exhibited cto (chronic total occlusion-100%) stenosis.There were no abnormalities reported in relation to anatomy.There was no damage noted to packaging, i.E.Shelf carton, hoop/tray.There were no issues noted when removing the device from the hoop/tray.The ifu (instruction for use) was followed during preparation, procedure, post-procedure.A 4x80mm chocolate pta balloon was used for pre-dilation.The vessel was post-dilated.The device was not passed through a previously deployed stent.No resistance was not encountered when advancing the device.Resistance and removal difficulties were reported.The nosecone detached from the hawkone.It was reported nothing detached from the spider and remained intact upon removal.A cut-down was required to remove the spider, nosecone and sheath and the common femoral was patched.There were 2 inpact admirals used in the lesion afterward.

Manufacturer Narrative

Additional information: the complaint devices were safely removed from the patient with no issues.It was reported the vascular surgeon performed a cut down on the common femoral to remove the device and patched the vessel as per standard protocol.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• 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: 19032605
• MDR Text Key: 339246484
• Report Number: 9612164-2024-01577
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 05/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: H1-M
• Device Lot Number: 0011945930
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/23/2024
• Date Device Manufactured: 09/11/2023
• 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
• Treatment: EP SPD2-US-040-320 SPIDER FX, LOT#B691692
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male