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

Catalog Number H1-LX

Device Problems Material Deformation (2976); Material Protrusion/Extrusion (2979)

Patient Problem Embolism (1829)

Event Date 04/18/2018

Event Type  Injury  

Manufacturer Narrative

Image analysis: the customer provided photos / cine images from the procedure.Three photos provided were taken outside of the patient.One photo showed the aspiration being performed.The remaining two photos showed the distal assembly of the hawkone where a hole was noted that ran parallel to the laser drilled coils.One of the cine images provided showed the hawkone within the vessel with the cutter assembly advanced.No damage or issue of tissue potentially escaping from coiled housing could be identified.The remaining cine images provided have been reviewed and include various angles and focal points both prior to / post use with the hawkone device.The hawkone was returned for analysis with a cutter driver attached.No other ancillary devices were returned.The hawkone was inspected and a hole in the tecothane of the housing assembly which ran parallel with the laser drilled coils of the housing was observed.The hole was approximately 2 cm distal the cutter window and showed biological debris protruding from it.The location of the hole was on the plane of the opening of the cutter window (opposite guidewire tubing).The coils at the area of the hole showed uneven spacing and sigs of bending.The cutter was located within the housing at the edge of the observed hole.No functional testing was performed due to the possibility of further damaging the distal assembly while attempting to advance the cutter.If information is provided in the future, a supplemental report will be issued.

Event Description

The physician intended to use the use the hawkone lx 7f, to treat a 450 mm fibrous plaque lesion with 90% stenosis, in the right superficial femoral artery and popliteal artery.Artery diameter was 6 mm.It was reported the physician used a contra lateral approach, with 7fr non medtronic sheath.It was reported the sfa was diffusely diseased about 90-99% in the entire sfa with a healthy popliteal artery.A 6x40 non-medtronic stent was used from the ostium of sfa and 6x150 non-medtronic stent in the hunters canal extending to popliteal.A guide catheter and stiff 0.035 guidewire was used to cross sfa, then it was exchanged for a 0.014 non medtronic 300 mm wire.The h1-lx was prepped per ifu with no visible damage noted and inserted into the patient to treat the entire sfa.After several passes were made, the nosecone was filling up and the physician started to feel a little resistance when packing the device.The catheter was safely removed for cleaning.After cleaning was performed per ifu, the catheter was inspected and no visible damage was noted.The device was turned on and off several times to inspect the cutter blade and it was reported to have been working properly.The catheter was re-inserted into the patient.After making several passes the physician felt the same resistance closing the thumbswitch and the nosecone was not packing and the catheter was removed for inspection.On removal from the sheath, a hole in the nosecone was noted with plaque protruding out of it.An angiogram confirmed embolization of the plaque protruding through the nosecone into the anterior tibial (at) and occluding outflow distally.Aspiration was performed to remove the plaque that embolized into anterior tibial.Once flow was re-established in the at, the procedure was completed using an in.Pact admiral dcb to treat the sfa/ popliteal.An angiogram confirmed that the outflow was established and the procedure was successfully completed.No further patient injury was reported.

• 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: 7518136
• MDR Text Key: 108388362
• Report Number: 2183870-2018-00277
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 00821684057933
• UDI-Public: 00821684057933
• 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: 05/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/11/2018
• Device Catalogue Number: H1-LX
• Device Lot Number: A146037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2015
• 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: 50 YR
• Patient Weight: 91