MAUDE Adverse Event Report: COVIDIEN HAWKONE 7F; CATHETER, PERIPHERAL, ATHERECTOMY

Catalog Number H1-LS

Device Problems Deformation Due to Compressive Stress (2889); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/26/2018

Event Type  malfunction  

Manufacturer Narrative

Product analysis: the hawkone was returned connected to a cutter driver.The device was received with the cutter and thumb switch in the forward position and the cutter was approximately 1.5cm distal from the cutter window.No other ancillary devices were included.During visual inspection, a 90-degree bend beneath the torque shaft and a tear to the tecothane layer were observed.The tear to the tecothane layer of the housing ran parallel to the laser drilled coils on the top plane of the housing (opposite the guidewire tubing) approximately 1.8cm distal the cutter window.The area of the observed hole was inspected under microscope.The coils were bent outward from the area of the observed hole and biological debris was observed at the area of the tear.If information is provided in the future, a supplemental report will be issued.

Event Description

The physician was attempting to use a hawkone directional atherectomy device to treat a 250 mm plaque lesion in the distal left superficial femoral artery/ popliteal artery.Little vessel tortuosity and little calcification were reported.The lesion percentage stenosis was 60-99%.Vessel diameter was 4-5mm.The device was prepped as per the ifu with no issues identified.The vessel was not pre-dilated.When taken out to clean it was noted that there was a protrusion on the side of the device of plaque atypical with normal nose cone function.Also seen on angiogram after initial pass was a bend in the shaft of the cutter/plunger.It was possible to open/ close cutter.No embolic material reported in spiderfx used in case.No harm to patient.The procedure was completed using a drug coated balloon.

• Brand Name: HAWKONE 7F
• 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: 7808194
• MDR Text Key: 117960850
• Report Number: 2183870-2018-00420
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 00643169968486
• UDI-Public: 00643169968486
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141801
• 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: 08/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/13/2019
• Device Catalogue Number: H1-LS
• Device Lot Number: A388882
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/13/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Weight: 71