MAUDE Adverse Event Report: MEDTRONIC, INC. MEDTRONIC; HAWK ONE DIRECTIONAL ATHERECTOMY SYSTEM

Catalog Number HI-14550

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

Patient Problem Tissue Damage (2104)

Event Date 11/26/2019

Event Type  malfunction  

Event Description

Device broke off during procedure.Required femoral cutdown to retrieve foreign body.

• Brand Name: MEDTRONIC
• Type of Device: HAWK ONE DIRECTIONAL ATHERECTOMY SYSTEM
• Manufacturer (Section D): MEDTRONIC, INC. ; 710 medtronic pkwy; minneapolis MN 55432
• MDR Report Key: 9397117
• MDR Text Key: 169018724
• Report Number: 9397117
• 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: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/19/2022
• Device Catalogue Number: HI-14550
• Device Lot Number: 0009603207
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/27/2019
• Distributor Facility Aware Date: 11/26/2019
• Event Location: Hospital
• 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 Age: 79 YR
• Patient Weight: 95