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

Model Number H1-S

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 03/01/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that a physician was attempting to use a hawkone atherectomy device to treat a soft tissue lesion in the mid right superficial femoral artery with little tortuosity and moderate calcification.Sheath (b)(4) size used was 6 fr cordis, vessel was not pre-dilated but was post dilated.It was reported that tip detached / tip damage occurred - the nosecone separated from catheter and was successfully removed from the patient.No further patient injury reported for this event.

Manufacturer Narrative

Additional information the vessel being treated was the anterior tibial artery.Pre-dilation was performed.No post-dilation was performed.There was no resistance noted when advancing or removing the device.The detached portion was snared to the common femoral artery (cfa).The detached portion could not be removed percutaneously and so surgery exposed the common femoral artery.The separated nosecone was located in the superficial femoral artery (sfa) and a non-medtronic balloon was advanced, and the piece removed.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Product analysis: the guidewire was inspected and found one end was looped and bent around itself multiple times.This end of the guidewire showed a ductile fracture face.The coiled flexible tip was bent at an approximate 45-degree angle.The approximate length of the guidewire was 44cm.The hawkone distal assembly was fractured apart.The fracture occurred distal the anchor pockets and at the proximal edge of where the coils of the housing initiate.The distal portion of the hawkone that had fractured apart showed the tecothane disengaged from the housing over the anchor pockets.The hollowed holes from the pockets were visible on the detached assembly.The coil within the tecothane was stretched proximally.The approximate length of the distal assembly which fractured apart was 6 cm.The guidewire lumen segment of the housing showed the proximal portion flapped over distally and the remaining guidewire lumen showed a zipper tear.The guidewire tubing of the rotating tip remained intact.The proximal portion of the hawkone showed the cutter advanced outside of the cutter window attached to the cutter driver.The cutter head was advanced approximately 2.7 cm distal the cutter window.The cutter remained bonded to the distal end of the driver shaft.The fracture face of the housing was radial.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Received medwatch report mw5085272.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 8389620
• MDR Text Key: 137794611
• Report Number: 9612164-2019-00770
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 00643169968356
• UDI-Public: 00643169968356
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/25/2021
• Device Model Number: H1-S
• Device Catalogue Number: H1-S
• Device Lot Number: 0009405384
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0451-2022
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 75 KG