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

Model Number H1-M

Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problem Injury (2348)

Event Date 10/21/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Physician was using a hawkone directional atherectomy along with 2 non medtronic 6fr sheaths and.014 nitrex guide wire to treat a moderately calcified lesion in the left mid sfa, popliteal and tibial/popliteal trunk with chronic total occlusion (cto-100%).The vessel diameter and lesion length are 5mm and 200mm respectively.The vessel was pre and post dilated.Ifu was followed during preparation, procedure and post procedure.It was reported that the tip detached and separated at the hinge pin.The device was inserted, removed, and cleaned per ifu four times.Nothing out of the ordinary was noted.On the fifth and final insertion the device had a different auditory tone.The device was turned off, then on again to cut and seemed to function properly with normal sound.When the device was pulled back under fluoro, the entire nosecone detached from the shaft.The intact shaft and push rod were removed without difficulty.With the nitrex wire being flossed from the femoral sheath though the pedal sheath, a 2.5 x 80 rx balloon was inserted via the pedal access and used to advance the detached nosecone to the distal tip of the femoral sheath.The nosecone was unable to advance into the femoral sheath.The sheath dilator was inserted and buttressed against he nosecone.Pinning the dilator and nitrex wire together, the nosecone entered the sheath and removed.Angios were taken, and procedure was finished with a series of pta from tibial to proximal sfa.No emboli noticed on angio.The patient sustained no injuries or complications.Both pieces of the product were recovered.

Manufacturer Narrative

Device evaluation: visual inspection: the hawkone was inspected and observed the distal assembly was fractured apart.The distal portion was not returned.The fracture face was radial.The cutter and drive shaft were exposed outside of the fractured area.The location of the fracture was distal the anchor pockets and at the proximal edge of the coils.No other damages or anomalies were observed.Cine image review: the customer provided a single cine image of the hawkone inserted the vessel.The cine showed the housings separated distal of the cutter window with the cutter and drive shaft exposed within the vessel.The detached segment showed no further damages on the cine.The cine image is consistent with the condition of the returned hawkone was received.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

Additional information: the pta performed to complete the procedure was carried out using a 6 x 150 evercross balloon.It is unknown if hinge pins were captured.It seemed that all device parts were removed over the wire and there was no emboli noticed on angio.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: 9218748
• MDR Text Key: 163959226
• Report Number: 9612164-2019-04464
• 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,Followup
• Report Date: 02/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: H1-M
• Device Catalogue Number: H1-M
• Device Lot Number: 0009810297
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2019
• 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
• Patient Sex: Male