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

Model Number H1-M

Device Problems Difficult to Advance (2920); Material Deformation (2976); Positioning Problem (3009); Physical Resistance/Sticking (4012)

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

Event Date 08/09/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Physician was attempting to use the hawkone atherectomy h1-m device along with non medtronic 6fr sheath and 0.014" guidewire to treat a little calcified soft tissue lesion in the proximal superficial femoral artery(sfa).The vessel was little tortuous.This was a bypass graft present.The vessel was post dilated and ifu was followed.It was reported that the hawkone was unable to cross.There was moderate resistance on initial advancement.The physician was able to use the hawk hm-1 for the proximal lesion but it did not pack and was not possible to advance.The orange switch would not move forward after the first pass.Upon inspection it looked as if the blade was stuck in the cutter window.When the physician tried to move it forward the plunger came out through the cutter window outside of the nosecone.Cutter was not in nosecone during removal because it would not go forward.No difficulty removing the device.No damage noted to tecothane jacket noted.No detachment occurred.The procedure was completed by using a 0.014" nanocross device followed by a hawkone h1-s device.No patient injury reported.

Manufacturer Narrative

Device evaluation visual inspection of the device shows damage at the proximal end of the tip assembly.Visual inspection under a microscope shows damage to the metal coils at the proximal end of the housing, just distal to the cutter window.The cutter returned inside the cutter window and the cutter driver was powered on and the cutter rotates but the cutter will not advance past the damage on the housing.A 0.014¿ guidewire from the lab was front loaded via the distal tip and exited out the proximal end of the gw lumen with no difficulty.Image review one photograph was received from the account for evaluation.The photo shows the distal tip assembly of the hawkone in vitro post usage.Biologics are visible on the tip assembly and damage is noted to the housing at the proximal end just distal to the anchor pockets.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
• MDR Report Key: 12359052
• MDR Text Key: 267850149
• Report Number: 9612164-2021-03262
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 00643169968332
• UDI-Public: 00643169968332
• Combination Product (y/n): N
• PMA/PMN Number: K161361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2024
• Device Model Number: H1-M
• Device Catalogue Number: H1-M
• Device Lot Number: 0010603933
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2021
• Date Manufacturer Received: 09/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 72 YR