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

Catalog Number H1-LX-INT

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/07/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Physician was attempting to use a hawkone atherectomy device for the treatment of left proximal-mid superficial femoral artery (sfa) stenosis.Sfa had little tortuosity and moderate calcification.The lesion was a chronic total occlusion with 100% stenosis.The vessel was not pre-dilated.Sfa diameter 50 mm in diameter with 150 mm lesion length.Ancillary devices used were a 7fr non-medtronic sheath and a spider 0.014 guide wire.Ifu was followed with no issues identified.It is reported that the thumb slide on the cutter driver became stuck and would not close completely, so blade could not be completely closed.It is unknown if the blade fully returned to the housing but it was determined that the risk to the patient would have been too great to continue.Following a clean, the slide mechanism was smoother, but upon second use it would not close.The procedure was completed using a new hawkone successfully.No deformation was noted on the cutter.No patient injury reported.

Manufacturer Narrative

Device evaluation; the hawkone was removed from the pouch and inspected.The torque shaft was bent at an approximate 90 degree angle beneath the strain relief.The thumb switch was located in a retracted position and the cutter was located within the cutter window.Traces of dried blood was noted within the cutter window.The cutter driver was powered, and it activated as intended.The thumb switch was attempted to be advanced but encountered resistance.The cutter was unable to enter the housing.The cutter encountered resistance as it entered the distal rim of the cutter window.Traces of dried blood was observed behind the cutter.If information is provided in the future, a supplemental report will be issued.

• Brand Name: HAWKONE 7FR
• 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: 8281720
• MDR Text Key: 134224991
• Report Number: 9612164-2019-00342
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K141801
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/28/2019

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: 08/28/2021
• Device Catalogue Number: H1-LX-INT
• Device Lot Number: 0009301733
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/07/2019
• Initial Date FDA Received: 01/28/2019
• Supplement Dates Manufacturer Received: 06/26/2019
• Supplement Dates FDA Received: 06/28/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/29/2018
• 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