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

Model Number	H1-M
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	02/08/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Image analysis: seven photographic images of the device were received for evaluation five of the photographic images are of the distal segment of the distal assembly.The guidewire is through the distal tip and appears to be torn from the guidewire lumen over the coil section of the distal assembly.Two photographic images are of the distal segment and proximal segment of the distal assembly along with the cutter/drive shaft.The distal assembly separated just distal of the cutter window where the coil segment of the distal assembly starts.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician intended to use a hawkone 67f, 7f sheath and 6.0 spider fx, to treat a moderately tortuous, calcified lesion, with 60-70% stenosis, in the proximal, mid and distal superficial femoral artery (5-6mm diameter),.The device was prepared as per ifu.It was reported that the physician encountered resistance while removing the hawkone and the tip of the device detached.A vascular cut down was performed to remove the tip of the hawkone from the patient.
Additional Manufacturer Narrative
Hawkone was returned with inserted cutter driver.There was no damage to the torque shaft.The cutter assembly and drive shaft were intact and pushed forward.The fracture of the distal assembly occurred distal the vent holes.The fracture shows the as the laser drilled coils star, they are stretched out at the area of the fracture.The damage to the h1 is consistent with a prolapse event.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: 7323813
• Report Number: 9612164-2018-00481
• Device Sequence Number: 109896
• Product Code: MCW
• UDI-Device Identifier: 00643169792302
• UDI-Public: 00643169792302
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/17/2020
• Device Model Number: H1-M
• Device Lot Number: A510625
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2018
• Initial Date Received by Manufacturer: 02/08/2018
• Supplement Date Received by Manufacturer: 03/23/2018
• Initial Report FDA Received Date: 03/08/2018
• Supplement Report FDA Received Date: 04/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Weight: 86