MAUDE Adverse Event Report: MEDTRONIC, INC. HAWKONE M ATHERECTOMY DEVICE; CATHETER, PERIPHERAL, ATHERECTOMY

Catalog Number H1-M

Device Problems Break (1069); Material Deformation (2976)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/30/2022

Event Type  Injury  

Event Description

While intervening on the patients left sfa, the hawkone m atherectomy device nose cone broke off inside the patient.The guidewire prolapsed , damaging the tip and causing it to break off.The doctor was able to successfully retrieve the device.Fda safety report id# (b)(4).

• Brand Name: HAWKONE M ATHERECTOMY DEVICE
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): MEDTRONIC, INC.
• MDR Report Key: 15503181
• MDR Text Key: 300897947
• Report Number: MW5112324
• Device Sequence Number: 1
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: H1-M
• Device Lot Number: 0011079948
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Native Hawaiian Or Other Pacific Islander