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

Catalog Number H1-LS-INT

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/12/2021

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 hawkone directional atherectomy along with non-medtronic 7fr sheath, guidewire and a 6. 0 spider embolic protection during procedure to treat a severely calcified lesion in the proximal common iliac artery and common femoral artery with 80% stenosis. The vessel was severely tortuous. Procedural stroke cineradiography images provided. The vessel was pre and post dilated. Ifu was followed. The device was unable to cross. There was severe resistance felt during third advancement. Another hawkone device was able to cross. It was reported that physician used a non-medtronic 4. 0x80mm pta balloon for pre dilatation to prepare the lesion for the delivery channel of hawk debulking afterwards. When physician tried third advancement of hawkone-ls and felt moderate to severe resistance, however hawkone catheter finally crossed the target lesion. But when he tried to do the forth advancement, hawkone catheter was totally stuck in y connector, he gently and slowly pulled hawkone catheter out from y connector, but the nosecone was damaged and separated from the catheter. Physician then tried another smaller model of hawkone (6fr compartible) and finally debulked most of the calcified lesion and used inpact pacific 7. 0 x 80mm to complete the procedure. No patient injury.

• Brand Name: HAWKONE 7FR
• 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: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 11185234
• MDR Text Key: 228003543
• Report Number: 9612164-2021-00208
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K141801
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 03/31/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 01/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: H1-LS-INT
• Device Lot Number: 0010105781
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2021
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/30/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/23/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial