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

Model Number H1-LS

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 06/10/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Physician attempted to use a hawkone atherectomy device during treatment of a 20cm plaque lesion in the patient¿s mid left superficial femoral artery (sfa).Artery diameter reported as 5mm.No vessel tortuosity or calcification were reported.The device was inspected with no issues noted.The device was prepped per the ifu with no issues identified.Per the scrub using the device in the case, the device was prepped in normal standard fashion with what seemed to be part of the flush valve popping out of place, which was identified prior to use in patient.The device was used properly with the spider fx embolic protection device with a total of three passes made before cleaning.During the cleaning a piece of ¿in-organic¿ material was retrieved from the nose cone itself.The in-organic material is not from patient and has not be identified.It did not appear to be the ptfe liner as it is white in appearance.The spider was not damaged during procedure.The case was completed with another h1-m device without incident.No patient injury reported.

Manufacturer Narrative

Device evaluation the distal end of the handle (that connects to the cutter driver) did not return for evaluation.A small piece of unknown plastic material with biologics within the material was also returned for evaluation inside the packaging with the device.The cutter returned inside the housing at approx.2.4cm distal from the cutter window.No damage noted to the nosecone, guidewire lumen or metal housing.Possible pet/tecothane material is noted in the flush window of the device.Functional testing could not be carried out due to the condition of the returned device.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
• MDR Report Key: 12049133
• MDR Text Key: 257804824
• Report Number: 9612164-2021-02441
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 00643169968486
• UDI-Public: 00643169968486
• Combination Product (y/n): N
• PMA/PMN Number: K141801
• 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: 07/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/19/2022
• Device Model Number: H1-LS
• Device Catalogue Number: H1-LS
• Device Lot Number: 0009747705
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2021
• Date Manufacturer Received: 07/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 55 YR