MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 HAWKONE 6FR; CATHETER, PERIPHERAL, ATHERECTOMY

Model 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	01/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation visual inspection: the hawkone was inspected and observed the distal flush tool (dft) was placed over the distal assembly.Looking through the distal assembly, it was noted the drive shaft was protruding out from the distal assembly.The dft was attempted to be removed from the distal assembly after removing the duckbilled valves from the dft; however the distal assembly could not be removed.With direct lighting applied under the microscope, it was verified the cutter assembly was secured to the distal end of the drive shaft.It was discovered while attempting to remove the distal assembly from the dft, a radial ductile fracture occurred at the distal rim of the cutter window.The damage showed the laser drilled coil was penetrated and split apart.There was no indication any portion of the distal assembly fragmented and separated from the unit.The distal portion of the distal assembly was inside the dft.The distal assembly and drive shaft/cutter assembly could not be removed because drive shaft which penetrated out from the laser drilled coils the drive shaft/cutter assembly interfered with the ability to remove the dft at the proximal opening.It should be noted a blue fibrous material was observed wrapped around the cutter assembly.
Event or Problem Description
The physician was using a hawkone one atherectomy catheter to treat a lesion.The device was prepped as per the ifu with no issues i entified.The procedure used a 0.014" guidewire and a 6 fr sheath.The vessel was not pre-dilated.Following the second cleaning of the device the tip detached outside of the patient.The tip did not separate at the hinge pin.No resistance was encountered.The procedure was completed by post dilation with an ipa balloon catheter.

• Brand Name: HAWKONE 6FR
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 9992009
• Report Number: 2029214-2020-00390
• Device Sequence Number: 11687471
• Product Code: MCW
• UDI-Device Identifier: 00643169728769
• UDI-Public: 00643169728769
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 04/23/2020

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: 11/08/2019
• Device Model Number: H1-M
• Device Catalogue Number: H1-M
• Device Lot Number: A372374
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2020
• Initial Report FDA Received Date: 04/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1