MAUDE Adverse Event Report: COVIDIEN HAWKONE 6FR; CATHETER, PERIPHERAL, ATHERECTOMY

Catalog Number	H1-M
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	11/06/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medwatch report number mw5081383.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Physician used a hawkone device during treatment of the patients right superficial femoral artery (sfa).It tis reported that the device failed to work properly and was unable to be removed from the body in the way it went in.A snare was attempted by failed, because device could not be dislodged.A bilateral groin cut down had to be performed and lower access by the right ankle.The device did break in the body and was retrieved from the aorta.An emergency cut-down was done to retrieve the device under fluoroscopic visualization.It was reported the 0.014 wire had gotten tangled around the nosecone resulting multiple loops around the tip.This was in the middle of the wire and after that continued down into the sfa.
Additional Manufacturer Narrative
Additional information: it is reported the patient¿s popliteal artery was the target treatment vessel.The vessel is reported as being slightly tortuous.Lesion described as focal calcium.No resistance was encountered when advancing the device.A detachment did not occur, the tip became bent leading to retrieval difficulties requiring the cut down for removal.It was reported that the thumbswitch was turned off and the cutter was safely inside the nosecone.If information is provided in the future, a supplemental report will be issued.

• Brand Name: HAWKONE 6FR
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): COVIDIEN; 9775 toledo way; irvine CA 92618
• MDR Report Key: 8169361
• Report Number: 1030489-2018-01653
• Device Sequence Number: 16495554
• Product Code: MCW
• UDI-Device Identifier: 00643169792302
• UDI-Public: 00643169792302
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K161361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/29/2020
• Device Catalogue Number: H1-M
• Device Lot Number: A516437
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/03/2018
• Supplement Date Received by Manufacturer: 01/02/2019
• Initial Report FDA Received Date: 12/17/2018
• Supplement Report FDA Received Date: 01/21/2019
• 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: Required Intervention