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

Model Number	H1-M
Medical Device Problem Codes	Fracture (1260); Defective Device (2588)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/07/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
It was reported that the physician was attempting to treat a lesion in the right sfa using atherectomy.The lesion was reported to have exhibited no calcification or tortuosity with 70% stenosis.The vessel diameter was reported to be 6mm and lesion length was reported to be 60mm.It was reported that the device would not close.Multiple attempts were made to debulk and close the device.It was reported that tissue was captured but the thumb switch would not move forward.Once removed from the patient, it was reported that the device was able to be opened and closed.A dcb balloon was used to post dilate the lesion with excellent results.There was no injury to patient reported.
Additional Manufacturer Narrative
Device evaluation: the hawkone was received for evaluation.The hawkone was received inserted a cutter driver with no other ancillary devices.The cutter was advanced approximately 2.7 cm distal the cutter window.No damages were noted to the cutter assembly, however the top plane of the laser drilled coiled segment showed bending.The thumb switch was retracted and the cutter assembly pulled back into the cutter window as intended.No resistance was experienced.The thumb switch was advanced and the cutter did not move.It was discovered the drive shaft was exposed from the strain relief.The strain relief was cut off and observed a ductile fracture to the torque shaft on each fracture face of the separation.The thumb switch was retracted and the torque shaft fracture faces came back to together.The drive shaft remained intact.The distance between the fractured torque shaft was approximately 3 cm with the thumb switch fully advanced.As the torque shaft was fractured and separated at the location of the strain relief this would allow the cutter to be retracted, but the cutter could not be advanced without manipulation of the torque shaft.
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: 6218384
• Report Number: 2183870-2017-00006
• Device Sequence Number: 738461
• Product Code: MCW
• UDI-Device Identifier: 00643169728769
• UDI-Public: 00643169728769
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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,consum
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/10/2017

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: 10/13/2017
• Device Model Number: H1-M
• Device Lot Number: A346308
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2017
• Initial Date Received by Manufacturer: 12/07/2016
• Supplement Date Received by Manufacturer: Not provided; 01/10/2017
• Initial Report FDA Received Date: 01/03/2017
• Supplement Report FDA Received Date: 02/07/2017; 09/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1