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

Model Number H1-M

Device Problems Deformation Due to Compressive Stress (2889); Material Deformation (2976); Physical Resistance/Sticking (4012)

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

Event Date 06/02/2021

Event Type  malfunction  

Manufacturer Narrative

Product analysis: the hawkone device returned coiled and connected to the cutter driver inside 3 biohazard bags.No ancillary devices were returned for analysis.Device was decontaminated with cidex opa solution soak and tergazyme soak.Visual inspection shows the drive shaft broken at the proximal end of the housing.The cutter window is damaged/pinched, and the proximal end of the housing is detached from the anchor pockets.The cutter returned inside the housing at approx.0.6cm distal from the anchor pockets.No damage noted to the guidewire lumen, nosecone, or distal end of the housing assembly.If information is provided in the future, a supplemental report will be issued.

Event Description

Physician attempted to use a hawkone atherectomy device with a 6fr non-medtronic sheath and 6mm spider fx embolic protection device during treatment of a calcified and plaque lesion in the patient¿s mid left superficial femoral artery (sfa).Slight vessel calcification is reported.Ifu was followed.Vessel pre-dilation was not performed.It is reported the physician had difficulty when advancing the thumbswitch to close the cutter window.The physician was able to eventually close and remove from patient.The cutter was inside the housing unit during removal.The device was removed safely from patient.After removal noticed damage to the nosecone/tip.No chips noted in the cutter.It looked like a kink where the nose cone and catheter meet.No components detached.Another h1-m was opened and used to complete procedure.There is 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: 12251277
• MDR Text Key: 264339489
• Report Number: 9612164-2021-02950
• 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
• Report Date: 07/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/23/2024
• Device Model Number: H1-M
• Device Catalogue Number: H1-M
• Device Lot Number: 0010576724
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/26/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2021
• 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
• Patient Age: 75 YR