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

Model Number HI - 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  

Event Description

Tip of hawk one became disconnected, and was inside the artery.

• Brand Name: HAWKONE TURBOHAWK
• Type of Device: CATHETER, PERIPHERAL ATHERECTOMY
• Manufacturer (Section D): MEDTRONIC IRELAND
• MDR Report Key: 8074326
• MDR Text Key: 127356545
• Report Number: MW5081284
• Device Sequence Number: 0
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/25/2021
• Device Model Number: HI - S
• Device Lot Number: 0009256641
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/14/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 82 YR