MAUDE Adverse Event Report: MEDTRONIC IRELAND HAWK ONE THERECTOMY CATHETER; CATHETER, PERIPHERAL, ATHERECTOMY

Model Number H1-S

Device Problems Entrapment of Device (1212); Difficult to Remove (1528); Device Dislodged or Dislocated (2923)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/28/2020

Event Type  Injury  

Event Description

Physician performing a peripheral atherectomy with turbo hawk device.After six passes, physician felt resistance when trying to remove device.Called in another surgeon for assistance to snare device and found blade was detached from device and stuck in sheath.Retrieval was successful and no other complications.Fda safety report id# (b)(4).

• Brand Name: HAWK ONE THERECTOMY CATHETER
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): MEDTRONIC IRELAND
• MDR Report Key: 10137984
• MDR Text Key: 194859032
• Report Number: MW5094920
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 06/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2022
• Device Model Number: H1-S
• Device Lot Number: 0010018420
• Was Device Available for Evaluation?: No
• 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): Required Intervention
• Patient Age: 49 YR
• Patient Weight: 149