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

Catalog Number H1-S

Device Problems Fracture (1260); Noise, Audible (3273); Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/16/2019

Event Type  malfunction  

Manufacturer Narrative

Image review: three photographs were returned for review.The first photograph received showed the hawkone rotator assembly disconnected from the slide cover, the drive shaft was exposed and bent.The thumb-switch remained attached to the spring retainer.A fracture was noted in the rotator assembly collar.The second photograph displayed the rotator assembly and spring retainer completely detached from the slide cover.The slide cover remained loaded within the cutter driver.The thumb-switch was no longer connected to the spring retainer.No fracture of the drive shaft was noted.The third photograph provided was an image of the spring retainer.The spring retainer was no longer within the slider cover and remained attached to the drive shaft.The photographs provided were consistent with the returned device.Product analysis: the hawkone device was returned for evaluation.No ancillary device was returned with the hawkone and cutter driver.The device was removed from the return packaging for inspection.The hawkone was received with the slide cover inserted the cutter driver.The rotator assembly was detached with drive shaft assembly exposed.The thumb-switch was detached from the rotator assembly.A fracture was noted on the slide cover.A bend was noted in the drive shaft located 59.9cm distal to the rotators proximal end.Examination of the cutter driver revealed no anomalies.The slide cover, rotator assembly, and thumb-switch were able to be reassembled successfully.Examination of the distal assembly revealed the cutter fully retracted into the cutter window.The distal flushing tool (dft) was covering the hawkone distal assembly.Biological debris was noted within the dft and the hawkone distal housing.The cutter driver was powered, and the thumb-switch was advanced into the distal housing.No abnormal noises were noted when the cutter driver was powered on.The cutter was able to advance approximately 2.6cm distal to the cutter window.The cutter was then retracted into the cutter window.No issues were noted during retraction.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.

Event Description

Physician was using a hawkone directional atherectomy along with a non medtronic 6fr sheath and.014 guide wire to treat a moderately calcified lesion in the left proximal anterior tibial artery with 70% stenosis.The vessel is moderately tortuous.The vessel diameter and lesion length are 3mm and 7mm respectively.The vessel was not pre dilated but post dilated.Ifu was followed during preparation, procedure and post procedure.It was reported that when hawkone device was packed, it made a funny noise.The thumbswitch was able to be turned off.The entire device was removed safely from the patient.The device was not completely attached when removed and the cutter was in the housing.After removal, it was difficult to pull the thumbswitch back and the entire thumb switch, including the battery, detached itself from the catheter outside the body.Another hawkone was used to complete the procedure.There was no patient injury reported.

• 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: 9254380
• MDR Text Key: 174044832
• Report Number: 9612164-2019-04531
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/19/2021
• Device Catalogue Number: H1-S
• Device Lot Number: 0009505417
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/24/2019
• Initial Date FDA Received: 10/30/2019
• Supplement Dates Manufacturer Received: 12/02/2019
• Supplement Dates FDA Received: 12/06/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/20/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1