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

Model Number	H1-14550
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/06/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Failed medical device.During the right leg angiogram/atherectomy device.Covidien by medtronic failed to work properly and was unable to be removed from the body in the way it went in.Snare was attempted but failed, because device could not be dislodged.Bilateral groin cut down had to be performed and lower access by the right ankle.Device did break in the body and was retrieved from the aorta.Emergency cut down was done to retrieve the device.Under fluoroscopic visualization, able to see 0.014 wire had gotten tangled around the nosecone resulting in multiple loops around the tip.This was in the middle of the wire and after that continued down into the sfa.

• Brand Name: COVIDIEN HAWKONE DIRECTIONAL ATHEROTOMY SYSTEM
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): COVIDIEN LLC / MEDTRONIC, INC.
• MDR Report Key: 8079077
• Report Number: MW5081383
• Device Sequence Number: 19232327
• Product Code: MCW
• UDI-Device Identifier: 00643169792302
• UDI-Public: 00643169792302
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/29/2020
• Device Model Number: H1-14550
• Device Catalogue Number: H1-M
• Device Lot Number: A516437
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 63 YR
• Patient Weight: 108