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

Model Number	H1-LS
Medical Device Problem Codes	Peeled/Delaminated (1454); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/28/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Physician attempted to use a hawkone atherectomy device and spider fx embolic protection device with a 7fr non-medtronic sheath during treatment of a 250mm calcified lesion in the patient's mid left superficial femoral artery and popliteal artery.Slight vessel to rtuosity and severe calcification are reported.Artery diameter reported as 6mm.Lesion exhibited 80% stenosis.Ifu was followed.The vessel was not pre-dilated.  it is reported the spider fx would not pull back into catheter when prepping.A new spider fx was opened and used.It is reported during use of the hawkone device the material from nosecone ¿line¿ came off.It was the line on the nose cone used to show that the quidewire lumen is lined up.The line was observed to be missing from the outer marker for wire lumen that did come out of the patient with the device.Physician was not aware of the detachment inside the patient.Recognized the defect when removed for cleaning.Imaging did not lead physician to believe there was a foreign body left.Atherectomy device was used in patient.Replacement hawkone device was used.No patient injury reported.When the device was returned for evaluation, it was noted that the lumen was fully detached.
Additional Manufacturer Narrative
Product analysis a visual inspection of the returned device found that the guidewire lumen was completely detached and missing from the nosecone.If information is provided in the future, a supplemental report will be issued.

• Brand Name: HAWKONE 7F
• Common Device Name: 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: 14010948
• Report Number: 9612164-2022-01312
• Device Sequence Number: 5317421
• Product Code: MCW
• UDI-Device Identifier: 00643169968486
• UDI-Public: 00643169968486
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K141801
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/05/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/08/2024
• Device Model Number: H1-LS
• Device Catalogue Number: H1-LS
• Device Lot Number: 0010636854
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2022
• Initial Report FDA Received Date: 04/05/2022
• Date Device Manufactured: 04/09/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 75 KG