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

Catalog Number	H1-M
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/06/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Physician was attempting to treat a moderately calcified lesion with severe tortuosity and 90% in the right sfa using spider fx and 2 hawkone atherectomy devices.The lesion was pre and post dilated.The device was prepped as per ifu.It was reported that the physician experience severe resistance during withdrawal of the first hawkone device and the tip broke and separated.The guideiwre locked up on the catheter.A spider wire was caught on the hawk one.The wire pulled out of wire port on tip, both were removed in tandem.Then a 2nd hawkone was used.It was reported that the second hawkone would not pack and a third hawkone was opened to complete the procedure.There was no injury to patient.
Additional Manufacturer Narrative
Correction to manufacturer address.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
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 (IRVINE); 9775 toledo way; irvine CA 92618
• MDR Report Key: 6217762
• Report Number: 2183870-2017-00001
• Device Sequence Number: 19012077
• Product Code: MCW
• UDI-Device Identifier: 00643169728769
• UDI-Public: 00643169728769
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/10/2017
• Device Catalogue Number: H1-M
• Device Lot Number: A346296
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/06/2016
• Supplement Date Received by Manufacturer: Not provided; 12/06/2016
• Initial Report FDA Received Date: 01/03/2017
• Supplement Report FDA Received Date: 01/03/2017; 09/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1