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

Catalog Number H1-LX

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/12/2018

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

The physician used a hawkone device with a 7fr non-medtronic sheath and a 0.014¿ spider fx to treat a 400mm moderately calcified/fibrous lesion presenting chronic total occlusion (100%) in the right superficial femoral artery (sfa).The vessel presented minimal tortuosity.Artery diameter was 5mm.Ifu was followed.Pre-dilation was conducted.The device was used and cleaned 3 times with no issues noted.It was reported that during the 4th attempt the thumbswitch would not advance.Another hawkone was used to complete the procedure.No patient injury was reported.

Manufacturer Narrative

Additional information: the thumbswitch was turned off and the cutter was withdrawn into the nosecone but it did not pack all the way into the nosecone.The device was safely removed from the patient.No cutter deformation was reported.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Device evaluation: the hawkone was received with the distal flush tool placed over the distal assembly.The cutter rim was inside the housing and the cutter blank was visible within the cutter window.The distal flush tool was removed from the distal assembly.It was observed dried blood and possible contrast was located behind the cutter.A bend to the housing was noted approximately 1 cm distal the cutter window.Dried blood/contrast was observed behind the cutter within the cutter window.The cutter driver was powered on and the thumb switch was retracted.The cutter driver powered on as intended.The thumb switch was advanced, but the cutter advanced approximately 1.2cm distal the cutter window.No debris was observed within the flush mouth of the distal assembly.The dft was placed over the distal assembly and flushed with water.The thumb switch was advanced, but the cutter encountered resistance at 1.2cm distal the cutter window.If information is provided in the future, a supplemental report will be issued.

• Brand Name: HAWKONE 7F
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 8163976
• MDR Text Key: 130332904
• Report Number: 9612164-2018-03628
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 00643169968509
• UDI-Public: 00643169968509
• 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,Followup,Followup
• Report Date: 03/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/12/2021
• Device Catalogue Number: H1-LX
• Device Lot Number: 0009378351
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/12/2018
• Initial Date FDA Received: 12/14/2018
• Supplement Dates Manufacturer Received: 01/18/2019; 03/01/2019
• Supplement Dates FDA Received: 02/13/2019; 03/13/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/13/2018
• 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 Age: 71 YR