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

Model Number H1-M

Device Problem Detachment Of Device Component (1104)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 02/08/2018

Event Type  Injury  

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 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.

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
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): COVIDIEN; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): COVIDIEN; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 7323813
• MDR Text Key: 101889408
• Report Number: 9612164-2018-00481
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 00643169792302
• UDI-Public: 00643169792302
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 04/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Weight: 86