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

Model Number H1-S

Device Problems Difficult to Advance (2920); Material Deformation (2976)

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

Event Date 02/26/2021

Event Type  malfunction  

Manufacturer Narrative

Image review: a total of 3 images were received from the customer.All 3 images show the plaque exiting through the middle of the housing.The customer complaint that ¿ plaque was coming out of the side¿ can be confirmed as it is consistent with the images returned by the customer.If information is provided in the future, a supplemental report will be issued.

Event Description

Physician intended to use a hawkone atherectomy device with a trailblazer during an attempt to revascularize the tibial vessels and popliteal artery.Severe vessel calcification and tortuosity are reported.Ifu was followed.A non-medtronic 6fr sheath was used.The device was successful in crossing other locations without issue.When attempting to cross a plaque lesion in the patient¿s proximal anterior tibial artery (at), it is reported that moderate resistance was noted during initial advancement of the device.The physician successfully got through the near occlusion in the anterior tibial artery with the wire and had issues advancing the trailblazer past the lesion.The physician then decided to perform atherectomy on the popliteal lesion and the proximal portion of the at.When shaving the lesion and the take-off of the at, the device pushed back as it tried to pass the lesion.Multiple attempts to advance were made but the device kept pushing back.The hawkone was removed from the patient for cleaning and it was noted when trying to clean the device the nosecone was bent, and plaque was coming out of the side.The tecothane jacket was not torn or ripped.The device was not used after this.Trailblazer and hawkone devices were removed safely from patient.A nanocross pta balloon was used to complete the procedure.No patient injury reported.

• 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: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 11525020
• MDR Text Key: 240955560
• Report Number: 9612164-2021-01044
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 00643169968356
• UDI-Public: 00643169968356
• 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
• Report Date: 03/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2022
• Device Model Number: H1-S
• Device Catalogue Number: H1-S
• Device Lot Number: 0010040773
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2021
• Date Device Manufactured: 12/02/2019
• 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