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

Catalog Number H1-M

Device Problem Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/05/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The physician was using an hawkone to treat a 50-60mm moderately calcified lesion with 70% stenosis in the left mid / proximal common femoral artery.The vasculature was moderately tortuous and the vessel diameter was 6-7mm.A 6mm non medtronic sheath, a 0.14 non medtronic guidewire and a 4-7mm non medtronic embolic protection was used in the procedure.The ifu was followed.It was reported that the plunger in the nose cone stopped operating.Another hawkone was used to complete the procedure.No patient injury was reported.

Manufacturer Narrative

Additional information: the position of the cutter upon removal of the device is unknown.The device was safely removed from the patient.No deformation was noted in the cutter.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Device evaluation visual inspection: the hawkone was inspected and observed the torque shaft beneath the strain relief was bent at an approximate 135-degree angle.The cutter driver power switch was in the off position.The distal assembly was inspected and observed a bend to coiled housing approximately 1.4 cm from the cutter window.The cutter was positioned approximately 1.2cm distal the cutter window.Tissue/biological debris was observed at the distal rim of the cutter.Traces of dried blood was noted within the cutter window.Functional testing: the torque shaft was straightened by hand and the cutter driver was powered on.The thumb switch was retracted, and the cutter was pulled back into the cutter window as intended.No damages to the cutter assembly were noted.The thumb switch attempted to be advanced but could not go further than the original location.The dft was placed over the distal assembly and flushed with water.Not all of the observed biologics could be flushed.The thumb switch was attempted to be advanced and could not pass the cutter window.It is possible damage to torque shaft and/or biologics behind the cutter may have interfered with the ability to advance.Image review the customer provided 2 cine images from the procedure.Both images show the lesion within the vessel with the guidewire inserted.The first image shows the what appears to be the distal assembly of the hawkone inserted the vessel.The provided cine could not identify the with certainty the location of the suspected cutter heard.The second photo shows the vessel with a guidewire placed within the vessel, but no ancillary devices appear loaded over the wire.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: 8498863
• MDR Text Key: 141459294
• Report Number: 9612164-2019-01256
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 00643169968332
• UDI-Public: 00643169968332
• 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: 07/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/06/2022
• Device Catalogue Number: H1-M
• Device Lot Number: 0009524427
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/12/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/07/2019
• 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
• Patient Age: 68 YR
• Patient Weight: 87