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

Model Number H1-14550

Device Problem Material Twisted/Bent (2981)

Patient Problem No Code Available (3191)

Event Date 11/06/2018

Event Type  Injury  

Event 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
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): COVIDIEN LLC / MEDTRONIC, INC.
• MDR Report Key: 8079077
• MDR Text Key: 127845348
• Report Number: MW5081383
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 00643169792302
• UDI-Public: 00643169792302
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• 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): Other
• Patient Age: 63 YR
• Patient Weight: 108