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

Catalog Number H1-M-INT

Device Problems Use of Device Problem (1670); Detachment of Device or Device Component (2907)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 04/12/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the physician was using a hawkone h1-m device with a non-medtronic 6fr sheath and 0.014 spider fx 5mm embolic protection device during treatment of a 40mm severely calcified cto (chronic total occlusion-100%) in the patient¿s mid proximal right superficial femoral artery (sfa) of diameter 5mm.No tortuosity was reported.The ifu was followed during preparation, procedure and post procedure and the device was prepped without issue.The vessel was pre-dilated.It was reported that during the procedure the blade would not go back in to the nose cone.When retracting the device back in to the sheath, resistance was felt.Upon further retraction, the device broke and the wire was seen to loop beneath the distal tip.The tip remained in the patient and was held by the wire of the spiderfx.The tip was retrieved by using a gooseneck snare.The procedure was completed by pta and placement of an everflex entrust stent.There was no patient injury reported.

Manufacturer Narrative

Additional information: the thumbswitch was turned off, the cutter driver was shut down the blade could not be advanced into the nosecone.The patient was discharged from the hospital without any complications or symptoms related to the procedure.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Image review: the customer provided 4 cine images and one photo of the hawkone device post-procedure.Image¿s #1 <(>&<)> #2 show the hawkone distal assembly inserted the vessel loading over a guidewire with the distal tip.It could not be conclusively identified if the housing was fractured.Image #3 shows the hawkone post-procedure with the housing fractured at the proximal location of where the coils initiate.The cutter is observed as exposed outside of the fracture face.The distal segment was not included the photo.Image #4 focused on the tip detachment.The cine shows where the separation occurs.Image # 5 shows the hawkone distal assembly inserted the vessel loading over a guidewire with the distal tip.The distal end of the sheath is visible.No damages were observed.Product analysis: the hawkone was returned connected to a cutter.No other ancillary devices were included.The hawkone was removed from the packaging and inspected.It was observed the distal assembly was fractured apart.The fractured off distal assembly was taped to the cutter driver.A radial fracture was observed between the anchor pockets and proximal end of the coiled segment of the housing.The portion of the distal assembly taped to the cutter driver was removed.The distal fractured off piece showed the proximal end of the tecothane with a smooth edge where it detached from the cutter window housing.The platinum iridium coils within the tecothane were stretched out proximally, past the tecothane.The length of the detached distal assembly was approximately 6cm.Biological debris was observed within the housing id.No damage to the guidewire tubing was observed.The proximal end of the separation showed a straight radial fracture.The cutter was retracted back into the cutter window.A 0.014" guidewire (gw) from the lab was front loaded both gw lumens of the distal assembly.No tears to the tubing was noted as the distal assembly was arched.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: 8513873
• MDR Text Key: 141919087
• Report Number: 9612164-2019-01336
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K161361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/02/2021
• Device Catalogue Number: H1-M-INT
• Device Lot Number: 0009308680
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/12/2019
• Initial Date FDA Received: 04/15/2019
• Supplement Dates Manufacturer Received: 04/18/2019; 05/31/2019; 01/19/2022
• Supplement Dates FDA Received: 05/16/2019; 06/26/2019; 02/16/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/03/2018
• 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-0450-2022
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male