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

Catalog Number H1-M

Device Problems Battery Problem (2885); Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/12/2018

Event Type  malfunction  

Manufacturer Narrative

Product analysis: the hawkone was returned connected to a cutter driver.No other ancillary devices were included.During visual inspection, it was noted that the hawkone was connected to a cutter driver with the power switch in the on position.Biological debris was observed within the distal assembly and the cutter was approximately 2cm distal of the cutter window.No structural damage to the hawkone or cutter driver was noted.During functional testing, the thumb-switch was retracted and the cutter was pulled back into the cutter window.The cutter driver did not activate.Biological debris was observed behind and in front of the cutter head.The thumb switch was advanced and the cutter was able to advance approximately 2.3 cm distal of the cutter window.The hawkone was removed from the cutter driver and connected to a cutter driver from the lab.The cutter driver was powered on and the thumb switch was retracted.The cutter driver motor activated as intended.The cutter driver was opened and the battery was replaced with a lab 9v battery.After replacing the battery, re-connecting the hawkone and retracting the thumb-switch, the cutter driver activated as intended.The battery was connected to a multimeter in the lab and indicated 8.95 v.A batter from a known operation cutter driver was measured at 9.60v.If information is provided in the future, a supplemental report will be issued.

Event Description

The physician was using a hawkone device with a non-mdt 6fr sheath and non-mdt.014 guidewire for the treatment of a 60mm, 80% stenosed plaque lesion in the mid left superficial femoral artery (sfa).The vessel was described as being non-tortuous and the artery diameter was 6mm.The vessel was not pre-dilated.The ifu was not followed.This event occurred intrastent and the device passed through a previously deployed unknown stent.It is reported the motor of the hawkone device stopped running.The thumb switch could be turned off but the cutter was positioned outside of the housing.The device was safely removed from the patient with no deformation noted in the cutter and an angioplasty was performed.No patient injury was reported.

• 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: 7333400
• MDR Text Key: 102211603
• Report Number: 9612164-2018-00499
• 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
• Type of Report: Initial
• Report Date: 03/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/10/2020
• Device Catalogue Number: H1-M
• Device Lot Number: A489429
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/11/2017
• 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