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

Catalog Number H1-S

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/29/2018

Event Type  Injury  

Manufacturer Narrative

Medwatch report number: mw5081284.If information is provided in the future, a supplemental report will be issued.

Event Description

It is reported that the tip of the hawkone detached inside the patients artery.No further information was provided.

Manufacturer Narrative

Additional information: the physician used the hawkone with a 6f terumo sheath and spider fx embolic protection device, to treat a heavily calcified lesion in the right superficial femoral artery.Ifu was followed with no issues noted, vessel was minimally tortuous, lesion length 200mm.It was reported severe resistance was encountered removing the hawkone.The tip did not separate at the hinge pin.A surgical cut down was performed to remove the tip of the hawkone.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: 8164138
• MDR Text Key: 130333742
• Report Number: 9612164-2018-03631
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/15/2019

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: 07/25/2021
• Device Catalogue Number: H1-S
• Device Lot Number: 0009256641
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/03/2018
• Initial Date FDA Received: 12/14/2018
• Supplement Dates Manufacturer Received: 01/28/2019
• Supplement Dates FDA Received: 02/15/2019
• Date Device Manufactured: 07/26/2018
• 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): Other; Required Intervention