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

Model Number H1-M

Device Problems Break (1069); Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/17/2019

Event Type  Injury  

Event Description

Device (medtronic hawkone directional atherectomy system) was being removed from pt and the 5.9cm end of device got lodged on calcium and was broken off.The physician tried to remove (unsuccessful snaring) the device piece, but was unsuccessful due to being lodged on the calcium.Vascular surgeon was called and the pt was taken to the operating room for a femoral endarterectomy.Fda safety report id# (b)(4).

• Brand Name: HAWKONE DIRECTIONAL ATHERECTOMY SYSTEM
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): MEDTRONIC, INC. ; minneapolis MN 55432
• MDR Report Key: 8540719
• MDR Text Key: 142819997
• Report Number: MW5086050
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 00643169968332
• UDI-Public: (01)00643169968332(17)220130(10)
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/30/2022
• Device Model Number: H1-M
• Device Catalogue Number: H1-14550
• Device Lot Number: 0009568220
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Weight: 95