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

Model Number H1-M

Device Problems Difficult to Remove (1528); Device Damaged by Another Device (2915); Device Contamination with Chemical or Other Material (2944)

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

Event Date 09/16/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Physician intended to use a hawkone atherectomy device with a 3mm spider fx and non-medtronic 6fr sheath during treatment of a 60mm, calcified cto (chronic total occlusion-100%) in the patient¿s mid and distal popliteal artery of reported diameter 4mm.Moderate vessel calcification is reported.Ifu was followed.Vessel pre-dilation and post-dilation was performed.The guidewire was hydrated at preparation.It is reported that the device was advanced over the bifurcation but that the moderate resistance was noted during withdrawal of the device.Tip damage is reported.The physician reports the guidewire was bunching and was noted by the end of the sheath during removal.The physician advanced the hawkone back down the wire and was able to resolve the wire wrap/bunching issue.The physician then removed the device from the patient with no further difficulty.Upon cleaning the device, a piece of black material was noted on the flush towel.A new hawkone was opened, and the procedure was completed successfully over the original spider wire, which was never removed from the patient.Post-dilation was performed with an inpact admiral drug coated balloon.No patient injury reported.

Manufacturer Narrative

Additional information: the source of the black material is unknown.There was no harm to the patient during this procedure, so the material had no effect on the outcome.There was no component detachment observed during the case and no visible issues with the device on inspection. the cutter was housed in the nose cone, in the off position when the device was removed from the patient.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.

Manufacturer Narrative

Product analysis: the hawkone device was returned to medtronic investigation lab for evaluation.The device was received within a white saftpak envelope.A device label sticker was adhered to the outside of the saftpak.The device was contained within multiple sealed plastic biohazard bags.No ancillary device returned.No images returned for review.The device was removed from the return package for evaluation.The cutter driver was returned attached to the catheter and a bend was observed in the torque shaft, beneath the strain relief.Biological debris was observed in the distal housing assembly.A bend was observed approximately 0.4cm and 1.3cm distal to the cutter window.No anomalies were observed with the guidewire lumen along the housing.Inspection of the lumen on the rotating distal tip revealed that the ink along the guidewire lumen of the tip had been removed in several locations.The cutter was returned advanced approximately 2.9cm distal to the cutter window.No anomalies were noted with the cutter window.Biological debris was observed in the housing; however, no foreign material was observed.No foreign material was observed in the flush window of the device.The cutter was retracted into the cutter window, no foreign debris was noted along the ridges of the cutter.A 0.014¿ guidewire was inserted into the guidewire lumen of the device.No anomalies were noted during advancement of the guidewire and no tearing was noted along the lumen.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: 10592447
• MDR Text Key: 208741945
• Report Number: 9612164-2020-03651
• 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,Followup,Followup
• Report Date: 12/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2020
• 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: 0010155368
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2020
• Date Manufacturer Received: 12/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1