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

Catalog Number H1-M

Device Problems Mechanical Problem (1384); Detachment of Device or Device Component (2907); Device Damaged by Another Device (2915); Material Deformation (2976)

Patient Problems Calcium Deposits/Calcification (1758); Stenosis (2263); Vascular Dissection (3160)

Event Date 06/20/2018

Event Type  Injury  

Manufacturer Narrative

The hawkone was returned for evaluation with the cutter driver attached.No ancillary devices were included.Visual inspection of the device was performed.The coiled housing of the distal assembly was fractured and separated.Approximately 1 cm of the housing was visible distal of the cutter window.The portion of the housing at the distal end showed the coil stretched out distally and a ductile fracture face.The distal portion which had fractured off from the rest of the unit was not returned.The cutter remained attached to the distal end of the drive shaft.The drive shaft/cutter assembly was intact and part of the returned hawkone.The torque shaft showed a bend of approximately 90 degrees beneath the strain relief.Functional testing was performed.The cutter driver was powered on and the thumb switch retracted.The cutter assembly was visible within the cutter window however, it could not be advanced out from the fractured portion of the distal assembly due to resistance.If information is provided in the future, a supplemental report will be issued.

Event Description

The physician was using a hawkone m directional atherectomy catheter with a 6mm spider filter wire to treat a 170mm severely calcified lesion with 95% stenosis in the mid right common iliac artery.The vessel had little tortuosity and a 5mm diameter.The device was prepped as per the ifu with no issues identified and the lesion was not pre or post dilated.Severe resistance was encountered during removal of the hawkone from the patient and the spider wire wrapped around the hawkone.When the hawk was pulled back during withdrawal from the patient, the spider wire wrapped and coiled tightly enough that the physician could not pull the device back through the sheath.The physician pulled the device hard and the tip of the hawkone detached from the catheter at the hinge pin.A cut down was performed at the access site and the spider wire was pulled using the cone of the filter to push the detached tip back through the iliac and over the aorta and out at the cut down site.Once the detached tip was removed from the body the physician used angiography to determine that there was no injury to the vessels as a result of the detachment.The physician reported that he believes that the basket of the spider was still on the tip of the device but could not accurately recall.The artery and groin were then sutured.

Manufacturer Narrative

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: 7701688
• MDR Text Key: 114406659
• Report Number: 9612164-2018-01790
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/03/2021
• Device Catalogue Number: H1-M
• Device Lot Number: 0009126174
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/04/2018
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Weight: 104