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

Catalog Number	H1-M
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/30/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician was attempting to use a hawkone directional atherectomy device to treat an 8 mm severely calcified lesion in the distal sfa.The vessel diameter was 6.0 mm with little tortuosity and 60% stenosis.No abnormalities were reported in relation to the patient¿s anatomy.The device was removed from its packaging and inspected with no issues noted.The device was prepped as per the ifu.A 6 fr non-medtronic sheath and a 0.014" non-medtronic guidewire were used during the procedure.No embolic protection was used.The vessel was not pre-dilated but was post-dilated.It was reported that severe resistance was met during withdrawal of the device.The tip of the device separated at the hinge pin during the second advancement.The tip was removed within the sheath.Guidewire prolapse was reported.A distal kink was noticed on the device after the second advancement during removal of the sheath.There was a 5 minutes timeline between the tip detaching and finding the kink.The procedure was completed using an unknown stent.No patient injury was reported.

• Brand Name: HAWKONE 6FR
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): COVIDIEN; 9775 toledo way; irvine CA 92618
• MDR Report Key: 7065573
• Report Number: 2183870-2017-00529
• Device Sequence Number: 16586757
• Product Code: MCW
• UDI-Device Identifier: 00643169792302
• UDI-Public: 00643169792302
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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
• Report Date (Section B): 11/28/2017

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: 06/29/2020
• Device Catalogue Number: H1-M
• Device Lot Number: A484888
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2017
• Initial Report FDA Received Date: 11/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 85 YR