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

Model Number H1-S

Device Problems Break (1069); Difficult to Insert (1316)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/14/2020

Event Type  Injury  

Event Description

Pt with peripheral vascular disease, limb ischemia; procedure was turbohawk directional atherectomy of right posterior tibial artery.Selective rt lower extremity angiography was obtained, dr exchanged sheaths for a 6 french raabe sheath given plan for atherectomy and his tortuous arteries.Used 0.014 command wire and a seeker cath to advance to the pt at the ankle.Confirmed in the true lumen.Tried to advance the hawkone unit; however, it would not pass through the pt, removed the device and used a 2mm balloon to treat the entire pl artery.Passed the device easily and performed atherectomy in multiple directions.Results excellent.When removing device, it caught when being resheathed and tip (nosecone) broke off.Dr removed the remainder of the device.It was clear the tip was stiff connected to the wire.Removed the entire sheath and wire as one unit in hopes of successfully removing the foreign body from the arterial system.Pulled the wire back as much as possible to get the majority of the device within the sheath, after removing the sheath, it was clear the foreign body remained in his left groin.Confirmed on fluoro.Marked his groin where foreign body appeared to be and took him to surgery emergently to remove the foreign body and also control the bleeding.

• Brand Name: HAWKONE MADE BY MEDTRONIC DIRECTIONAL ATHERECTOMY SYSTEM
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): MEDTRONIC, INC.
• MDR Report Key: 10717886
• MDR Text Key: 212732534
• Report Number: MW5097380
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 10/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/20/2023
• Device Model Number: H1-S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR