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

Catalog Number H1-S

Device Problem Contamination (1120)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/03/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the physician used a hawkone h1-s device with a non-medtronic 6fr sheath and 0.014 non-medtronic with no embolic protection device during treatment of a 50 mm plaque 85% stenotic lesion in the patient¿s mid popliteal artery of diameter 4-5 mm.No tortuosity and slight calcification were reported.Ifu was followed during preparation, procedure and post procedure.The vessel was not pre-dilated.It was reported that when the device was removed from the patient¿s body a blue substance which looked fibrous was noticed on the hawk catheter.The saline used was not a blue colour.The procedure was completed using balloon angioplasty.

Manufacturer Narrative

Product analysis: the hawkone was returned.The hawkone was attached to a cutter driver.No other ancillary devices were returned.The hawkone was removed from the packing and inspected.Approximately 12 cm proximal to the distal tip of the hawkone showed blue fibrous material compressed together.Inspected the distal assembly and torque shaft under microscope showed less concentrated blue fibers adhered to the outer circumference of the housing.The distal assembly showed the cutter advanced within the housing and did not identify blue fibrous material within the inner diameter of the coiled housing assembly.The distal flush tool (dft) was located pulled back at the area of the strain relief.No damages to the dft were observed.Under microscope, a blue material was identified at the area of the proximal face of the black duckbilled valve.The black duckbilled valve was pulled out from the dft and observed a concentrated/compressed blue fibrous material with the same physical characteristics as the blue fibers located 12cm from the distal tip of the hawkone.The manufacturing/design of the hawkone does not include components that may contain the blue fibrous material as shown on the exterior of the device.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

• Brand Name: HAWKONE 6FR
• 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: 8635638
• MDR Text Key: 145926310
• Report Number: 9612164-2019-01913
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 00643169968356
• UDI-Public: 00643169968356
• 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,Followup,Followup
• Report Date: 07/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/15/2022
• Device Catalogue Number: H1-S
• Device Lot Number: 0009541076
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/08/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/16/2019
• 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