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

Lot Number 0010461056

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem Insufficient Information (4580)

Event Date 04/26/2021

Event Type  malfunction  

Event Description

Plastic inside hawk.Fda safety report id # (b)(4).

• Brand Name: HAWKONE DIRECTIONAL ATHERECTOMY SYSTEM
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): MEDTRONIC IRELAND
• MDR Report Key: 12032650
• MDR Text Key: 257489559
• Report Number: MW5101986
• Device Sequence Number: 1
• Product Code: MCW
• 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: 06/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/18/2023
• Device Lot Number: 0010461056
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• 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