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

Model Number H1-LX

Device Problems Difficult to Insert (1316); Detachment of Device or Device Component (2907)

Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888)

Event Date 11/09/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Physician used hawkone directional atherectomy along with 7fr sheath, a non-medtronic guidewire and 6mm embolic protection during procedure to treat a moderately calcified lesion in the mid to distal left superficial femoral artery (sfa) with chronic total occlusion (cto-100%).The vessel diameter was 6mm.The vessel was not pre or post dilated.Ifu was followed.During withdrawal, severe resistance was felt and the tip detached/damaged.The hawkone tip was stuck inside the sheath pulling the spider with it.Physician was unable to take final pictures to assess damage after losing wire.Ultrasound will be performed in the afternoon post procedure.Physician was unable to complete, access was lost.Patient complication associated with this event is access site hemorrhage/bleed.No further patient injury reported.

Manufacturer Narrative

Product analysis: the hawkone was returned connected to a cutter driver inside a clear biohazard bag with a device sticker attaching indicating lot 0010287165.A green non-medtronic sheath was included.No other ancillary devices were included.The hawkone was inspected and found approximately 7cm of the guidewire tubing from the hawkone was torn off from the distal assembly.The hawkone was loaded through the sheath with approximately 60 cm of the hawkone catheter exposed outside of the sheath.The distal rim of the green sheath showed a longitudinal crease.An inspection of the distal assembly of the hawkone showed the cutter was positioned approximately 2.5cm distal the cutter window with dried biologics inside the housing.The proximal segment of the coiled housing showed the coils were crushed/flattened.Zipper tearing/disengagement of the guidewire lumen of the housing was observed throughout the entire segment of the coiled housing.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.

Manufacturer Narrative

Additional information: the tip did not completely detach inside the sheath.It was noted no intervention or medication was prescribed to the patient that was not normal.No procedure was performed to treat the lesion.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
• MDR Report Key: 10828322
• MDR Text Key: 215919450
• Report Number: 9612164-2020-04392
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 00643169968509
• UDI-Public: 00643169968509
• 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,Followup
• Report Date: 12/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/23/2023
• Device Model Number: H1-LX
• Device Catalogue Number: H1-LX
• Device Lot Number: 0010287165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2020
• Date Manufacturer Received: 12/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1