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

Catalog Number H1-LS

Device Problems Kinked (1339); Material Deformation (2976)

Patient Problem Intimal Dissection (1333)

Event Date 01/08/2018

Event Type  Injury  

Manufacturer Narrative

Evaluation summary: the hawkone was returned for evaluation inserted in a cutter driver.No other ancillary devices were included.The device was inspected and no damage was observed to the slide cover assembly or torque shaft.The distal assembly was bent at an approximate 45-degree angle approximately 4 cm distal to the cutter window.The tecothane layer was deformed and protruded out from the laser drilled coils.The area of the damaged tecothane noted was at the site of the 45-degree angle bend.The guidewire tubing was inspected under microscope and no signs of tearing/damage were found.If information is provided in the future, a supplemental report will be issued.

Event Description

The physician was attempting to use a hawkone atherectomy device to treat an 80 mm moderately calcified plaque lesion in the popliteal artery (60% stenosis).The artery diameter was 6 mm and had moderate tortuosity.The device was prepped as per the ifu with no issues identified.The procedure used a 7 fr non-medtronic sheath and a 6 mm spider guidewire.The vessel was not pre-dilated.The popliteal artery was successfully atherectomised.Damage was done to the nose cone when turning off the device in order to compact the plaque.The nose cone partially ruptured and kinked.The tip did not separate at the hinge pin.As the device was removed it caused a long dissection proximal to treated area (dissection occurred in the superficial femoral artery).The cutter returned to the housing and was in the distal nosecone.This area was then stented using a 6x80 stent (manufacturer unknown) and post dilated with good results.

• Brand Name: HAWKONE 7F
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 7259276
• MDR Text Key: 99601163
• Report Number: 2183870-2018-00069
• Device Sequence Number: 1
• Product Code: MCW
• 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: 02/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: H1-LS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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 Outcome(s): Required Intervention
• Patient Age: 67 YR