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

Catalog Number H1-M

Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907); Difficult to Advance (2920)

Patient Problem Embolism/Embolus (4438)

Event Date 03/04/2022

Event Type  Injury  

Event Description

Physician was attempting to use a hawkone directional atherectomy along with a non-medtronic 6fr 45cm sheath and a 0. 014" spider wire during procedure to treat a severely calcified lesion in the proximal superficial femoral artery (sfa). The vessel was not pre or post dilated. Ifu was followed. During withdrawal, moderate resistance was felt and the tip detached, it separated at the hinge pin. The became completely detached near the rapid exchange port. The guidewire lock-up/prolapse/lumen torn/ripped occurred. The device advanced over bifurcation but no resistance felt. Guidewire was hydrated at preparation. The guidewire prolapsed and it cause embolization. The guidewire tor from the distal tip but did not lock-up on the catheter. The tip was left in the body as was unable to be retrieved. Patient was sent to surgery for open retrieval. The target lesion was right ostial sfa. Hawkone device became stuck and tip dislodged due to wire wrap and prolapse upon removal. Multiple attempts were made to straighten out and unwrap wire with no success. Upon attempting to remove spider wire, hawk device, and sheath simultaneously the tip separated upon reaching the contra-lateral left common femoral side and became lodged into the left profunda artery. Multiple attempts were made to snare the spider wire an d tip from the contra-lateral side but were unsuccessful due to a hard protrusion from the proximal end of the tip becoming embedded in the arterial wall. Contra-lateral guide catheter and snare left in place with capture of spider wire basket and proximal tip with distal tip embedded in profunda artery. Patient was sent to the operating room for open retrieval. No further patient injury reported.

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 ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 13692155
• MDR Text Key: 286743615
• Report Number: 9612164-2022-00902
• Device Sequence Number: 1
• Product Code: MCW
• 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: Health Professional,Company Representative

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 06/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: H1-M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 03/08/2022 Patient Sequence Number: 1