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

Catalog Number H1-M

Device Problem Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/21/2019

Event Type  malfunction  

Manufacturer Narrative

Product analysis: the hawkone device was returned.No ancillary device or images were received with the device.The device was removed from the return packaging for evaluation.The cutter driver was attached to the hawkone device.It should be noted that the torque shaft was bent beneath the strain relief.Examination of the distal assembly revealed biological debris inside the distal housing.A bend was noted approximate 0.3 cm distal to the cutter window.Microscopic inspection of the bend revealed a tear in the tecothane coating at the location of the bend; the cutter was protruding through the tear in the tecothane.The laser drilled coils in the housing were fractured at the location of the cutter protrusion.If information is provided in the future, a supplemental report will be issued.

Event Description

Physician used a hawkone device during treatment of a lesion in the patient¿s superficial femoral artery (sfa).No abnormalities reported in relation to anatomy.Ifu was followed and the device was prepped without issue.No resistance was felt during advancement.Upon fluoro imaging, prior to cutting, it was reported that the tip of the device was bent.No passes were made and no cutter deformities were noted.The device was safely removed from the patient.The device was replaced to complete the procedure.There was no patient injury.

Manufacturer Narrative

Device evaluation the device was removed from the return packaging for evaluation.The cutter driver was attached to the hawkone device.It should be noted that the torque shaft was bent beneath the strain relief.Examination of the distal assembly revealed biological debris inside the distal housing.A bend was noted approximate 0.3cm distal to the cutter window.Microscopic inspection of the bend revealed a tear in the tecothane coating at the location of the bend; the cutter was protruding through the tear in the tecothane.The location of the hole was on the top plane of the coiled housing (opposite guidewire tubing).The proximal edge of the hole where the cutter was exposed was flapped down and below the cutter rim.The laser drilled coils in the housing were fractured at the location of the cutter protrusion.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: 8959039
• MDR Text Key: 156424123
• Report Number: 9612164-2019-03728
• 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
• Report Date: 09/11/2019

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: 04/24/2022
• Device Catalogue Number: H1-M
• Device Lot Number: 0009712603
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/30/2019
• Initial Date FDA Received: 09/04/2019
• Supplement Dates Manufacturer Received: 09/09/2019
• Supplement Dates FDA Received: 09/11/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/25/2019
• 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