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

Model Number	H1-M
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/09/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: returned contents: the hawkone was returned inside saftpak bio-hazardous packaging material.The hawkone was inserted the cutter driver.No other ancillary devices were included.Visual inspection: the hawkone was inspected and observed the distal end of the torque shaft was separated from the torque shaft adapter.No other damages were noted.Functional testing: the thumb switch was retracted and the torque shaft and torque shaft adapter would connect.When the thumb switch was advanced completely approximately 2.6cm were separating the two components.It should be noted the drive shaft remained intact so the device remained as one unit.The bond between the torque shaft adapter and the drive shaft was compromised and no longer intact.No other damages or anomalies were noted.
Event or Problem Description
The physician intended to use a hawkone directional atherectomy device to treat the superficial femoral artery as per ifu.It was reported the hawkone device started kicking back in vessel while cutting after only a few small passes.The packer could not be seen over x-ray.When removed from the patient, it was visible that the nosecone was almost completely detached from catheter.Another device was used to complete the procedure.No patient injury reported.
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; 9775 toledo way; irvine CA 92618
• MDR Report Key: 6611062
• Report Number: 2183870-2017-00239
• Device Sequence Number: 7104
• Product Code: MCW
• UDI-Device Identifier: 00643169728769
• UDI-Public: 00643169728769
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Report Date (Section B): 05/09/2017

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: 11/07/2019
• Device Model Number: H1-M
• Device Lot Number: A371669
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2017
• Initial Date Received by Manufacturer: 05/09/2017
• Supplement Date Received by Manufacturer: 05/09/2017
• Initial Report FDA Received Date: 06/05/2017
• Supplement Report FDA Received Date: 10/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1