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

Model Number H1-M

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Embolism (1829); Patient Problem/Medical Problem (2688)

Event Date 03/07/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The physician was using a hawkone to treat a severely calcified lesion in the superficial femoral artery (sfa).The ifu was followed.It was reported that the tip of the device and the nosecone detached and embolised in the patient and could not be brought back through the sheath.The physician re-accessed the site and successfully completed the procedure.

Manufacturer Narrative

Additional information: no resistance was encountered when advancing the hawkone system.The detached portion embolised in the patient's superficial femoral artery (sfa).A snare was used to retrieve the detached portion, no pieces were left in the patient.No resistance was encountered during the withdrawal of the hawkone system.The embolisation did not cause any injury to the patient.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Device evaluation: the hawkone was removed from the packaging and inspected.It was observed the distal assembly was fractured apart.A radial fracture was observed between the anchor pockets and proximal end of the coiled segment of the housing.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.Biological debris was observed within the housing id.It should be noted the guidewire tubing of the housing was protruding up at the proximal and a zipper tear was observed throughout the segment.The distal assembly housing showed a bend of approximately 45 degree at the flush mouth.The proximal end of the separation showed a straight radial fracture.The cutter was advanced approximately 2.7cm from the cutter window.Suspected pet was observed wrapped around the proximal end of the cutter head.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: 8412530
• MDR Text Key: 138536279
• Report Number: 9612164-2019-00842
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 00643169968332
• UDI-Public: 00643169968332
• 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
• 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: 01/02/2022
• Device Model Number: H1-M
• Device Catalogue Number: H1-M
• Device Lot Number: 0009515662
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2019
• Initial Date FDA Received: 03/12/2019
• Supplement Dates Manufacturer Received: 03/12/2019; 05/29/2019; 01/19/2022
• Supplement Dates FDA Received: 03/29/2019; 06/25/2019; 02/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/03/2019
• 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