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

Model Number H1-M

Device Problems Device Difficult to Setup or Prepare (1487); Material Deformation (2976)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/17/2020

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 a hawkone directional atherectomy, along with a 6fr non-medtronic sheath, and a non-medtronic guidewire (thruway, boston scientific) during procedure to treat a little calcified plaque lesion in the left mid superficial femoral artery (sfa) with 80% stenosis.The vessel diameter and lesion length were 6mm and 40mm respectively.The vessel was not pre dilated but post dilated.Ifu was followed.It was reported that physician was unable to advance distal flushing tool down, and had to force it in order to clean device.While cleaning the device, physician noticed the bulging midway on the nosecone.2 insertions/4 passes were performed before the cleaning issue and bulge was noted.The tecothane jacket appeared to have a hole in the nosecone.The tip did not detach.There was no removal difficulties.The device was removed with the cutter inside the housing from the patient.Physician opened a second device to complete the procedure.There was no patient injury reported.

Manufacturer Narrative

Product analysis: the device was received within a white saftpak envelope.Within the envelope, the device was loosely contained within multiple sealed biohazard bags.No ancillary devices or images were received.The device was removed from the return packaging.The catheter was attached to the cutter driver.The distal flushing tool (dft) was proximal to the housing assembly.Biological debris was noted in the housing.A bulge and bend was noted in the housing.The bulge was located approx.1.6cm distal to the cutter window.The bulge was located on the same plane as the cutter window.It was noted that the housing also bent at the location of the bulge.The cutter was also located approx.2.6cm distal to the cutter window.A blue discoloration, consistent with contrast was observed around the location of the cutter.Under microscopic inspection, tearing of the tecothane was observed.The inner laser drilled coils were stretched, bent, and separated at the location of the bulge.Biological debris was noted at the location.No anomalies were noted with the cutter window.Functional testing could not be performed due to the condition of the housing assembly.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
• MDR Report Key: 10676965
• MDR Text Key: 211280294
• Report Number: 9612164-2020-03911
• 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: 12/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/26/2023
• Device Model Number: H1-M
• Device Catalogue Number: H1-M
• Device Lot Number: 0010155376
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2020
• Date Manufacturer Received: 12/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1